77 Adam Jobs

As a Statistical Programmer at our company, you will play a crucial role in leading statistical programming activities for compounds/indications, managing a team of statistical programmers, and ensuring timely deliverables while upholding quality processes. Your responsibilities will include: - Leading the statistical programming activities for a compound/indication. - Managing a team of statistical programmers and planning resources effectively. - Developing SAS programs for creating ADaM data sets following CDISC standards. - Developing SAS programs for generating Tables, Listings, and Figures. - Ensuring consistency of ADaM data sets for individual studies and integrated data. - Creating documentation for regulatory filings, such as reviewers guides and data definition documents. - Leading the development of standard SAS Macros and contributing to standard operating procedures. - Providing oversight and mentoring to Statistical Programmers, Statistical Analysts, and Senior Statistical Analysts. To excel in this role, you should possess the following skillsets: - Experience in leading a team of statistical programmers for a compound/indication or therapeutic area. - Proficiency in SAS/R programming languages for programming and validating ADaM, TFL, and statistical analyses. - In-depth understanding of SAS programming concepts and techniques in drug development process and clinical study life cycle. - Familiarity with other statistical programming languages like R. - Knowledge of CDISC standards and therapeutic areas such as Oncology, Immunology, Neuroscience, etc. - Experience with regulatory filings. - Effective written and verbal communication skills. - Ability to represent the Statistical Programming Organization in cross-functional teams effectively. - Accurate estimation of effort required for project-related programming activities. - Collaboration in a team environment and adaptability to changing priorities and deadlines. Your qualifications should ideally include a degree in Life Sciences, Computer Science, or Statistics, along with a minimum of 2+ years of experience in SAS programming. Reporting to the Delivery Manager, you will be a key contributor to our Statistical Programming team in locations like Mumbai, Pune, or Bangalore. As a Statistical Programmer at our company, you will play a crucial role in leading statistical programming activities for compounds/indications, managing a team of statistical programmers, and ensuring timely deliverables while upholding quality processes. Your responsibilities will include: - Leading the statistical programming activities for a compound/indication. - Managing a team of statistical programmers and planning resources effectively. - Developing SAS programs for creating ADaM data sets following CDISC standards. - Developing SAS programs for generating Tables, Listings, and Figures. - Ensuring consistency of ADaM data sets for individual studies and integrated data. - Creating documentation for regulatory filings, such as reviewers guides and data definition documents. - Leading the development of standard SAS Macros and contributing to standard operating procedures. - Providing oversight and mentoring to Statistical Programmers, Statistical Analysts, and Senior Statistical Analysts. To excel in this role, you should possess the following skillsets: - Experience in leading a team of statistical programmers for a compound/indication or therapeutic area. - Proficiency in SAS/R programming languages for programming and validating ADaM, TFL, and statistical analyses. - In-depth understanding of SAS programming concepts and techniques in drug development process and clinical study life cycle. - Familiarity with other statistical programming languages like R. - Knowledge of CDISC standards and therapeutic areas such as Oncology, Immunology, Neuroscience, etc. - Experience with regulatory filings. - Effective written and verbal communication skills. - Ability to represent the Statistical Programming Organization in cross-functional teams effectively. - Accurate estimation of effort required for project-related programming activities. - Collaboration in a team environment and adaptability to changing priorities and deadlines. Your qualifications should ideally include a degree in Life Sciences, Computer Science, or Statistics, along with a minimum of 2+ years of experience in SAS programming. Reporting to the Delivery Manager, you will be a key contributor to our Statistical Programming team in locations like Mumbai, Pune, or Bangalore.

Role Overview: Birlasoft is looking for a Senior SAS Programmer to join their team. As a part of the multibillion-dollar CKA Birla Group, you will have the opportunity to work with a team of 12,500+ professionals committed to driving societal progress through innovative business solutions. Your role will involve developing complex tools and frameworks using SAS software within the Life Science Analytical Framework (LSAF) and providing programming support for clinical study reviews and QC processes. Additionally, you will be responsible for defining and developing maintenance or enhancements in multiple areas of domain expertise, providing training and support to colleagues, and participating in process improvement initiatives. Key Responsibilities: - Develop complex tools and frameworks using SAS software within Life Science Analytical Framework (LSAF) - Work independently on SAS programs to support services: developing, reviewing, and testing programs for clinical study reviews and QC - Define and develop maintenance or enhancements in multiple areas of domain expertise - Provide programming training, presentations, and support to colleagues - Participate in process, system, and tool improvement initiatives - Provide guidance in multiple domain expertise areas for non-trials/non-program projects - Support audit and inspections as appropriate - Move code through environments and into production (e.g., Release Process) Qualification Required: - Minimum Bachelors degree in Computer Science, Engineering, or related field - 7 years of relevant experience required - Experience in programming in SAS Life Science Analytical Framework (LSAF) required - Proven experience with SAS software and SAS programming in a clinical study environment - Proven experience in developing systems and system frameworks in SAS - Basic knowledge of SDTM & ADAM standards required - Knowledge of SAS Viya is a plus,

Role Overview: As an R&D Programmer III at Teva Pharmaceuticals, you will play a crucial role in providing high-level clinical programming support for clinical projects and regulatory submissions. Your responsibilities will include generating and validating analysis datasets, tables, listings, and figures. You will also contribute to the development of global data standards, such as SDTM, ADaM, and Teva's database structure. Additionally, you will lead departmental tasks, drive initiatives to enhance clinical programming processes, and focus on SAS Programming. Key Responsibilities: - Work at the project level and provide input for budget planning - Deliver assignments with quality and within timelines - Oversee contingent workers and/or vendors, and provide training as needed - Lead/co-lead clinical programming for a study or regulatory submission - Develop, review, document, and perform validation of generic SAS macros - Initiate and lead new processes, methodologies, and operational ideas to improve efficiency - Supervise and support outsourcing activities Qualifications Required: - Bachelor's Degree/Master's Degree/PhD in Science, Statistics, Information Technology, or equivalent combination of education and related work experience - Bachelor's Degree with 3 years or Master's Degree with 2 years in Science, Statistics, Information Technology, or equivalent combination of education and related work experience - Experience in SDTM and ADaM, familiar with CDISC Guidelines and requirements Additional Details: Teva Pharmaceuticals is on a mission to make good health more affordable and accessible worldwide. They are the leading manufacturer of generic medicines and produce many products on the World Health Organization's Essential Medicines List. With operations in nearly 60 countries and a diverse workforce, Teva is constantly striving to make a difference and welcomes new talent to join their mission of improving global healthcare. If you are passionate about clinical programming, contributing to impactful projects, and shaping the future of healthcare, we encourage you to apply for the R&D Programmer III position at Teva Pharmaceuticals.,

Role Overview: As a Data Scientist in the team, you will be responsible for developing and maintaining R programs to generate CDISC SDTM and ADaM datasets, as well as tables, listings, and figures to meet clinical trial data requirements. Key Responsibilities: - Ensuring compliance with industry standards and regulatory requirements - Collaborating with cross-functional teams to understand and implement project-specific data needs - Providing technical expertise and support for data analysis and reporting tasks - Performing quality control and validation of outputs to maintain accuracy and consistency Qualification Required: - A Bachelor's degree in a quantitative field such as Statistics, Mathematics, Computer Science, or Data Science - At least 3 years of experience in R programming, including familiarity with R packages used in data analysis and reporting for clinical trials - Knowledge of data visualization techniques and tools in R - Experience working with clinical trial data and understanding of CDISC ADaM and SDTM standards - Strong analytical and problem-solving skills - Excellent communication skills and the ability to work effectively in a team environment Desirable skills that would be beneficial for this role: - Knowledge of other open-source packages and tools - Experience with SAS software - Familiarity with CRAN, POSIT, and other open-source repositories and products (Note: The company also provides more information about EEO & Accommodations request for your reference.),

Role Overview: As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, you will be part of Fortrea, providing pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe. Key Responsibilities: - Develop and maintain R programs for generating CDISC SDTM and ADaM datasets and tables, listings, and figures in accordance with clinical trial data requirements - Ensure compliance with industry standards and regulatory requirements - Collaborate with cross-functional teams to understand and implement project-specific data needs - Provide technical expertise and support for data analysis and reporting tasks - Perform quality control and validation of outputs to ensure accuracy and consistency Qualifications Required: - Bachelor's degree in a quantitative field (e.g., Statistics, Mathematics, Computer Science, Data Science) - Minimum of 3 years of experience in R programming including familiarity with R packages used in the analysis and reporting of data for clinical trials - Familiarity with data visualization techniques and tools in R - Experience with clinical trial data and familiarity with CDISC ADaM and SDTM standards - Strong analytical and problem-solving skills - Excellent communication and ability to work in a team environment In addition, Fortrea is actively seeking motivated problem-solvers and creative thinkers who share the passion for overcoming barriers in clinical trials. The company's unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join the exceptional team at Fortrea and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.,

As an Implementation Consultant at our company, your role will involve the following key responsibilities: - Responsible for creating User Requirement Specifications (URS) and functional requirement specs in Clinical Reporting and Analytics. - Create wire-frames and mock-ups for Clinical reports. - Communicate with Clinical Data Management & Medical Reviewers to document the clinical reporting needs. - Stay up-to-date with all Saama product features and releases. - Analyze and understand current business processes, events, and flows in Clinical Trial Development. - Act as a Clinical Subject Matter Expert and provide Clinical Project Support. - Author and document business requirements, providing analytical support needed to translate requirements into solutions. - Create and maintain Data Mapping Specifications for Saama Data Review Model. - Incorporate feedback from customers, partners, and in-house teams on product. - Manage all aspects of projects related to implementation including guiding the client through release planning, managing communication, leading product implementation efforts, managing project team deliverables, documenting and reporting status and issues, identifying and managing risks, and acting as a client liaison. - Ensure a smooth transition of services from implementation to support. - Provide advanced analytical and reporting support to customers on various projects, solving complex problems and conducting complex analysis. - Support configuration and quality check with project teams to ensure the solution meets business objectives. - Help identify and define new sources of relevant data, analyze data, and make recommendations. - Support customer User Acceptance Testing (UAT) phase for any configuration change or issue triaging. - Understand and discuss the application and implications of changes to the process and relation to requirements. Desired Skills: - Experience in the Pharmaceutical industry is essential. - Good understanding of Clinical Systems such as EDC Systems (Medidata Rave, Veeva EDC, Oracle InForm, etc.), CTMS Systems (Siebel CTMS, Medidata CTMS, Veeva CTMS, etc.), IRT Systems (YPRIME, Parexel Clinphone, etc.), and LAB Systems (central Lab, local Labs, etc.). - Good experience in SQL. - Good understanding of the clinical trial domain, overall EDC study setup, and Clinical reporting. - Experience in building Clinical reports and dashboards. - Understanding of CDASH, SDTM, and ADAM standards. - Relevant degrees such as Bachelor's and Master's Degree in Healthcare, Computer Science, Technical, Engineering, Computer, Computer Engineering, Computer Programming - Bachelor's degree (BA) in computer science or equivalent work experience required. - 1-2 years of experience as a Product Owner. - Comfortable and familiar with the Agile Working Environment. - Experience working with all phases of Software Development Life Cycle (SDLC). - Familiarity with FDA regulations such as 21 CFR Part 11 and GxP is a bonus. - Experience working in the complete product life cycle of two or more products. - Technical knowledge including knowledge of Software Development and Web Development. - Experience with use and configuration of healthcare software applications (preferably clinical). As an Implementation Consultant at our company, your role will involve the following key responsibilities: - Responsible for creating User Requirement Specifications (URS) and functional requirement specs in Clinical Reporting and Analytics. - Create wire-frames and mock-ups for Clinical reports. - Communicate with Clinical Data Management & Medical Reviewers to document the clinical reporting needs. - Stay up-to-date with all Saama product features and releases. - Analyze and understand current business processes, events, and flows in Clinical Trial Development. - Act as a Clinical Subject Matter Expert and provide Clinical Project Support. - Author and document business requirements, providing analytical support needed to translate requirements into solutions. - Create and maintain Data Mapping Specifications for Saama Data Review Model. - Incorporate feedback from customers, partners, and in-house teams on product. - Manage all aspects of projects related to implementation including guiding the client through release planning, managing communication, leading product implementation efforts, managing project team deliverables, documenting and reporting status and issues, identifying and managing risks, and acting as a client liaison. - Ensure a smooth transition of services from implementation to support. - Provide advanced analytical and reporting support to customers on various projects, solving complex problems and conducting complex analysis. - Support configuration and quality check with project teams to ensure the solution meets business objectives. - Help identify and define new sources of relevant data, analyze data, and make recommendations. - Support customer User Acceptance Testing (UAT) phase f

As an Executive-SAS Programmer at Syngene in Bangalore, your role will involve performing SAS programming activities for Biometrics. Your key responsibilities will include: - Reviewing protocol - SAS programming of tables, listing and graphs as applicable - CDISC programming - Good Knowledge of SDTM and AdAM dataset - Good knowledge of SAP Additionally, you may be assigned other responsibilities by the organization from time to time. To qualify for this role, you should have an M.Sc. in Life Sciences and a Certification of SAS Programming. Your technical/functional skills should include being an expert in any programming language (preferably R and SAS) and Pinnacle, as well as having Clinical Trials Exposure in Pharmacokinetics and Phase I-IV. You should also have 3-4 years of experience in this field. Syngene International Ltd., incorporated in 1993, is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to various industries. The company's clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Syngene's innovative culture is driven by a strong team of scientists who work with clients worldwide to solve scientific problems, improve R&D productivity, speed up time to market, and lower the cost of innovation. Syngene is an Equal Opportunity Employer. As an Executive-SAS Programmer at Syngene in Bangalore, your role will involve performing SAS programming activities for Biometrics. Your key responsibilities will include: - Reviewing protocol - SAS programming of tables, listing and graphs as applicable - CDISC programming - Good Knowledge of SDTM and AdAM dataset - Good knowledge of SAP Additionally, you may be assigned other responsibilities by the organization from time to time. To qualify for this role, you should have an M.Sc. in Life Sciences and a Certification of SAS Programming. Your technical/functional skills should include being an expert in any programming language (preferably R and SAS) and Pinnacle, as well as having Clinical Trials Exposure in Pharmacokinetics and Phase I-IV. You should also have 3-4 years of experience in this field. Syngene International Ltd., incorporated in 1993, is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to various industries. The company's clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Syngene's innovative culture is driven by a strong team of scientists who work with clients worldwide to solve scientific problems, improve R&D productivity, speed up time to market, and lower the cost of innovation. Syngene is an Equal Opportunity Employer.

As a Lead Biostatistician at Atorus, you will be responsible for the overall statistical management of services for projects to ensure high quality and on-time delivery. You will provide statistical leadership and expertise into clinical development plans, concepts, and protocols. Your role will involve conducting statistical analysis, validating and interpreting statistical analysis results, and representing the company on Product Development Teams of sponsors. Your key responsibilities will include: - Providing statistical input into study protocols, Case Report Forms, and data management plans - Overseeing statistical analysis plans, statistical outputs, and other required documents - Generating statistical output for manuscripts and ensuring accurate interpretation in publications - Reviewing and contributing to study reports and regulatory submission dossiers - Managing biostatisticians and statistical programmers - Identifying and implementing innovative statistical methodology approaches - Developing strong collaboration with sponsor cross-functional teams and Biostatistics management To qualify for this role, you should have: - A Master's degree in Statistics, Biostatistics, or a related discipline (Ph.D. preferred) - 5-10 years of experience in statistical or biostatistical analysis supporting clinical trial operations in the pharma/biotech industry - Proficiency in SAS and/or R programming languages - Experience in sample size calculation, protocol development, and preparing clinical study reports for submissions - Strong understanding of CDISC requirements and ADaM specifications generation - Excellent communication skills and the ability to work effectively within a cross-functional team Preferred skills for this role include being an energized self-starter, having excellent organizational and communication skills, exceptional attention to detail, strong interpersonal skills, effective problem-solving abilities, sound decision-making skills, flexibility, and proven ability to prioritize workload effectively. Please note that familiarity with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, as well as knowledge of advanced statistical methods applicable to clinical trials, are also required for this position.,

As a Statistical Programmer L2 at our company, you will report to the Principal Statistical Programmer 3/ Lead, Statistical Programming (L4 (3) or M1). Your main responsibility will be to work independently on most of the Mapping activities, including SDTM and client-specific mappings of simple and medium complexity for the assigned client in the given environment for the standard domains. You will need to have a good understanding of the clinical domain, mapping logic, and data issues. Additionally, learning the product/system/mechanism to be used for SDTM mapping is a key part of your role. **Key Responsibilities:** - Ability to pick up multiple tools/technologies on the job - Import and Export raw data - Contribute to Mapping specifications - Utilize SAS/R programming/Python programming skills for clinical trial study submissions - Develop programs identifying data issues and reporting them to the appropriate team - Utilize appropriate guidelines to build CDISC/regulatory compliant datasets - Understand CRF annotations and check for consistency with raw data - Ability to debug custom functions/SAS Macros and fix issues - Good understanding of clinical data and domain - Follow Client Processes and SOPs - Assist senior team members in quality control processes - Assist senior team members with team metrics - Communicate with an internal team to create deliverables for pharmaceutical and CRO clients - Work in tandem with Biostatistics and Data Management members on clinical projects - Communicate with programming and statistics leads - Ensure compliance with company policies/SOPs **Qualifications Required:** - Graduation in Pharmacy/Computer Science, or any such equivalent graduation from a reputed institute - Total experience between 2 - 4 years - Clinical Domain knowledge - Familiarity with CDISC Standards (SDTM Knowledge, ADaM, Submission package) - SAS Programming (Experience up to 2 years) - Python Programming will be an added advantage - R Programming will be an added advantage - Good Communication skills, learning attitude, and good team player At our company, Saama automates key clinical development and commercialization processes with artificial intelligence (AI), Generative AI, and advanced analytics. We accelerate your time to market by offering AI-backed SaaS solutions as well as product-based industry services and accelerators. Discover more at saama.com.,

As a Manager Statistical Programming at Syneos Health, you will play a crucial role in the clinical development model by bringing the customer and patient to the center of all activities. Your contributions will help simplify and streamline work processes to make Syneos Health not only easier to work with but also easier to work for. You will collaborate with passionate problem solvers to innovate as a team and assist customers in achieving their goals. Your agile and driven mindset will accelerate the delivery of therapies, ultimately making a difference in changing lives. Key Responsibilities: - Possess strong end-to-end programming experience, including SDTM, ADaM, and TLF development. - Have at least 2 years of relevant experience in project and people management, overseeing project metrics, and leading a team of 20+ members. - Proficiency in R or Python is a plus. - Hands-on experience in safety and efficacy programming, including writing specifications for SDTM and ADaM datasets. - Work in Clinical Phases: Phase II, III, and IV. - Therapeutic Area: Any. Qualifications Required: - Strong end-to-end programming experience in SDTM, ADaM, and TLF development. - Minimum of 2 years of experience in project and people management. - Proficiency in R or Python. - Hands-on experience in safety and efficacy programming. - Ability to work in Clinical Phases II, III, and IV. In the past 5 years, Syneos Health has collaborated on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites with 675,000+ trial patients. This dynamic environment will challenge you to take initiative and challenge the status quo, contributing to the company's success. Please note that tasks, duties, and responsibilities may vary beyond those listed in this job description as per the Company's discretion. Equivalent experience, skills, and education will also be considered. The Company is dedicated to compliance with all applicable laws and regulations, including the provision of reasonable accommodations under the Americans with Disabilities Act. For further insights into Syneos Health, visit their official website at http://www.syneoshealth.com.,

As a data analyst at our company, you will be responsible for developing and maintaining a global R codebase to generate CDISC ADaM datasets, tables, listings, and figures in alignment with clinical trial data requirements. Your key responsibilities will include: - Ensuring compliance with industry standards and regulatory requirements - Collaborating with cross-functional teams to understand and address project-specific data needs - Providing technical expertise and support for data analysis and reporting tasks - Performing quality control and validation of outputs for accuracy and consistency - Contributing to process improvements and the development of programming standards using R To qualify for this role, you should have: - A Bachelor's degree in a quantitative field such as Statistics, Mathematics, Computer Science, or Data Science - A minimum of 3 years of experience in R programming, including familiarity with R packages like Tidyverse, ggplot2, and survival - Familiarity with data visualization techniques and tools in R - Experience with clinical trial data and knowledge of CDISC ADaM and SDTM standards - Knowledge of industry R packages like ADMIRAL and OAK - Strong analytical and problem-solving skills Desirable skills for this position include: - Knowledge of other open-source packages and tools - Familiarity with CRAN, POSIT, and other open-source repositories and products Join our team and be a part of our innovative approach to data analysis in the clinical trial domain.,

Hiring for Clinical Statistical Programmer Role !!! Apply now, if interested do share your resume prachiwfm187@gmail.com 8287816038 WE ARE HIRING FOR INDIA'S 2ND LARGEST KPO !!! Experience - 5+ Years Experience in Clinical SAS Programming (Inc. ADAM, TLF,CDISC Standards, Mapping & Conversion of Clinical Trial Data, Therapeutic Areas experience is must) Job location- Mumbai/Pune/Bangalore Note- You can forward this post to your friends and colleagues who wish to apply.  Thanks & Regards  Prachi Rawat  8287816038

Were Hiring  for Statistical Programmer (Healthcare Domain) ! Exciting Opportunity Awaits! Location: Mumbai , Chennai , Pune , Bangalore  Salary: Up to 22 LPA Shift: General Shifts Working Days: 5 Days WFO | 2 Rotational Offs Eligibility:Minimum 5 years of experience in Statistical Programming(R,SDTM,ADAM,SDLC) within the Healthcare domain Share your CVs: hrwfm.consultancy42@gmail.com Contact: Shruti 9911988551 References are highly appreciated!

As a Senior SAS Programmer at our company, you will be responsible for the following key responsibilities: - Providing SAS programming support for TFL generation. - Offering statistical/programming inputs for CRF design and review. - Developing and validating standard and ad-hoc SAS macros. - Conducting a review of CRF and aCRF. - Completing a review of statistical analysis plans. - Preparing programming specifications for efficacy variables. - Validating Safety Tables using SAS. - Preparing and validating ADaM and derived datasets and their specifications. - Validating SDTM datasets and their specifications. - Adhering to required training. Desirable Skills and Experience: - Experience in SAS. - Subject matter expertise for SDTM and ADaM datasets. Location: Chennai, India Qualifications: - Graduate/Post Graduate with a life sciences degree Role: Manager Department: Data Sciences Employment Type: Full Time As a Senior SAS Programmer at our company, you will be responsible for the following key responsibilities: - Providing SAS programming support for TFL generation. - Offering statistical/programming inputs for CRF design and review. - Developing and validating standard and ad-hoc SAS macros. - Conducting a review of CRF and aCRF. - Completing a review of statistical analysis plans. - Preparing programming specifications for efficacy variables. - Validating Safety Tables using SAS. - Preparing and validating ADaM and derived datasets and their specifications. - Validating SDTM datasets and their specifications. - Adhering to required training. Desirable Skills and Experience: - Experience in SAS. - Subject matter expertise for SDTM and ADaM datasets. Location: Chennai, India Qualifications: - Graduate/Post Graduate with a life sciences degree Role: Manager Department: Data Sciences Employment Type: Full Time

As an Implementation Consultant, you will be responsible for managing and assuming accountability for all aspects of projects related to implementation. Your key responsibilities will include: - Guiding the client through release planning in support of the overall project. - Managing communication throughout the team and stakeholders. - Leading product implementation efforts by coordinating with customers, product SME, and other teams. - Managing the quality of Implementation deliverables. - Documenting and reporting status on Risks, Issues, Actions, and Decisions. - Identifying, reporting, and managing risks; overcoming project obstacles. - Acting as a client liaison and representative by communicating client feedback to appropriate representatives and resolving outstanding issues on behalf of the client in a timely manner. - Understanding Clients clinical landscape and providing techno-functional solutions to evolving needs of the clients. - Analyzing and understanding current business processes, events, and flows in Clinical Trial Development and creating SOPs, Work instructions for the implementation/delivery team. - Ensuring a smooth transition of services from implementation to support. - Incorporating feedback and input from customers, partners, and in-house teams on saama product features. - Providing advanced analytical and reporting support to customers on various projects, solving complex problems, and/or conducting complex analysis. - Supporting configuration and quality check with project teams to ensure the solution will meet the business objectives of the requirements. - Helping identify and define new sources of relevant data, analyzing data, and making recommendations. - Understanding and discussing the application and implications of changes to the process and relation to requirements. Desired Skills: - Experience in the Lifesciences and Pharmaceutical industry is essential. - Good experience in SQL, APIs, and Integrations. - Good understanding of CDASH, SDTM, and ADAM standards. - Good understanding of EDC, CTMS, IRT, and LAB Systems. - Good understanding of the clinical trial domain, overall EDC study setup, and Clinical reporting. - Relevant degrees such as Bachelor's and Master's Degree in Healthcare, Computer Science, Technical, Engineering, Computer, Computer Engineering, Computer Programming - Bachelor's degree (BA) in computer science, or equivalent work experience required. - 3-5 years of experience as a Product Manager or 1-2 years of experience as a Product Owner. - Comfortable and familiar with the Agile Working Environment. - Experience working with all phases of SDLC. - Familiarity with FDA regulations such as 21 CFR Part 11 and GxP is a bonus. - Experience working in the complete product life cycle of two or more products. - Technical knowledge including knowledge of Software Development and Web Development. - Experience with use and configuration of healthcare software applications (preferably clinical).,

Role Overview: Are you a Clinical Data SME who enjoys transforming complex trial data into analysis-ready assets that drive scientific progress Join the data42 team at Novartis! The vision of data42 is to inspire collaborative groundbreaking data and AI initiatives to accelerate drug discovery, transforming healthcare and improving lives. As a Clinical Data SME, you will be the go-to expert for clinical trial data, working closely with data engineers and data scientists to ensure data quality and advance scientific research for patient impact. Key Responsibilities: - Collaborate with data engineers, data scientists, and stakeholders to assess data requests" feasibility based on scientific questions and fulfill use-case specific data needs. - Identify relevant Clinical Data domains and variables, interpret and transform them with a focus on pooling ADaM data across historical trials. - Conduct hands-on data quality assessments to validate data before delivery. - Share knowledge on clinical trial data, transformation logic, and mapping strategies within the team. - Contribute to documentation to enhance transparency in data transformation processes. - Seek continuous improvement opportunities. Qualification Required: - 3-5 years of experience with Clinical Trial data in a pharmaceutical or CRO setting, ideally within Neuroscience, Oncology, CRM, or Immunology therapeutic areas. - Excellent knowledge of CDISC data standards (SDTM, ADaM) and familiarity with relevant data dictionaries like MedDRA. - Expertise in pooling Clinical Trial ADaM datasets. - Experience in working with various legacy, historical, and local data standards. - Proficiency in working with clinical study documents (Protocol, CSR, etc.). - Hands-on experience in coding for data transformations using SQL, Python, R, etc. - Proficiency with SAS and PROC SQL. - Analytical mindset, attention to detail, and ability to assess data quality. - Demonstrated ability to work independently and in global Agile teams. - Fluency in English (oral and written) with strong communication skills. Additional Company Details (if present): Novartis is committed to creating an inclusive work environment and diverse teams that represent the patients and communities served. They offer benefits and rewards to help employees thrive personally and professionally. Novartis also provides accessibility and accommodation for individuals with disabilities during the recruitment process.,

As a data science-driven company focused on supporting faster drug development and healthcare solutions, MEDTEK AI's team is comprised of senior statisticians, data scientists, statistical modeling and programming experts, data visualization specialists, cloud data engineers, data lake strategists, and regulatory submission and drug safety consultants. In this role at MEDTEK AI, you will be involved in a hands-on programming position, supporting deliverables in the study/project/portfolio/standards team, focusing on medium or high complex statistical programming deliverables. Your responsibilities will include: - Demonstrating strong SAS data manipulation, analysis, and reporting skills with a focus on output programming experience. - Proficiency in implementing the latest CDISC SDTM / ADaM standards. - Applying familiarity with the drug development life cycle and experience in manipulating, analyzing, and reporting clinical trials data. - Developing and executing statistical analysis and reporting deliverables such as safety and efficacy analysis datasets, tables, listings, and figures. - Expertise in designing, developing, and ensuring quality control processes for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for all requested analyses. - Providing technical guidance to other statistical programmers, ensuring training and development of team members. - Leading and managing programming activities for clinical trials, including the development of programming plans, specifications, and programming datasets. Qualifications required for this role at MEDTEK AI include: - Bachelor or Master's (preferred) Degree in Statistics, Mathematics, Bioinformatics, or Computer Science. - Minimum of 8 years of relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency. - In-depth knowledge of clinical trial design, statistical analysis, and regulatory guidelines.,

Role Overview: As a Senior Statistical Programmer working fully embedded within a pharmaceutical client, supported by Cytel, you will play a crucial role in driving innovation and supporting global pharmaceutical clients in driving the next generation of patient treatment. You will have the opportunity to work autonomously and take ownership in a dynamic environment. Key Responsibilities: - Perform data manipulation, analysis, and reporting of clinical trial data using SAS programming - Generate and validate SDTM and ADaM datasets/analysis files, as well as tables, listings, and figures (TLFs) - Conduct production and QC/validation programming - Generate complex ad-hoc reports from raw data - Apply strong understanding/experience of Efficacy analysis - Create and review submission documents and eCRTs - Communicate with internal cross-functional teams and clients for project specifications, status, and inquiries - Lead duties when called upon - Be adaptable and flexible in response to changing priorities - Experience in Real-World Evidence (RWE) would be advantageous Qualifications: - Bachelor's degree in Statistics, Computer Science, Mathematics, or related fields - Minimum of 8 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree, or 6 years of experience with a master's degree or above - Study lead experience preferred, handling multiple projects simultaneously - Strong SAS data manipulation, analysis, and reporting skills - Proficiency in CDISC SDTM/ADaM standards - Strong QC/validation skills - Good ad-hoc reporting skills - Proficiency in Efficacy analysis - Familiarity with the drug development life cycle and clinical trial data analysis - Experience with submission documents and define.xml - Experience supporting immunology, respiratory, or oncology studies a plus - Excellent analytical and troubleshooting skills - Ability to deliver quality output within challenging timelines - Effective teamwork in a globally dispersed team environment - Experience in Real-World Evidence (RWE) would be an added advantage Additional Company Details: Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. With over thirty years of experience, Cytel's scientific rigor and operational excellence have helped biotech and pharmaceutical companies to navigate uncertainty and unlock the full potential of their data. Join a team where talent, experience, and scientific rigor collaborate to advance clinical development and contribute to the future of human health. Explore Cytel careers for opportunities in biostatistics, statistical programming, adaptive clinical trial design, and more.,

As a Team Member in the engineering department, your role involves understanding the impact of various vehicle dynamic parameters such as RHB, NVH, Drivability, crash, etc. and maintaining a balance between cost, weight, and efficiency. You will need to have a good grasp of terminologies related to fuel efficiency and emissions, and be able to estimate the impact of changing vehicle parameters on emissions. Your responsibilities also include collaborating with testing teams, correlating CAE results with physical testing outcomes, and enhancing CAE models based on the analysis. Key Responsibilities: - Understand and analyze vehicle dynamic parameters for optimal performance - Estimate the impact of changing vehicle parameters on emissions and fuel efficiency - Collaborate with testing teams and improve CAE models based on results - Predict market strategies of OEMs regarding powertrains, fuel types, and vehicle positioning Qualifications Required: - B.E/B.Tech/M.Tech in Mechanical/Automobile/Electrical Engineering - 6 to 7 years of experience in automotive engineering - Thorough knowledge of regulatory and testing guidelines (e.g. CAF, JC08, WLTP, MIDC) - Basic understanding of CAD software (e.g. UG NX) - Experience in project management and on-road driving - Proficiency in MS Office, UG-NX, and dynamic evaluation software like ADAMS In addition to the technical qualifications, hands-on experience with a Dyno and a background in project management will be advantageous for this role. Your ability to understand vehicle dynamics, analyze emission factors, and predict market trends will be key to success in this position.,

As a Senior Statistical Programmer at our company, you will play a crucial role in supporting the analysis and reporting of clinical trial data in compliance with regulatory standards. You will work closely with Biostatisticians, Data Managers, and Clinical Teams to contribute to the delivery of high-quality datasets, tables, listings, and figures (TLFs). Key Responsibilities: - Develop, validate, and maintain SAS programs to produce analysis datasets (ADaM, SDTM) and TLFs for clinical trial submissions. - Ensure accuracy, efficiency, and compliance with CDISC standards and regulatory guidelines in programming deliverables. - Collaborate with Biostatistics and Data Management teams to comprehend study requirements and timelines. - Contribute to the establishment of programming standards, macros, and process enhancements. - Offer mentorship and guidance to junior programmers, reviewing their work for quality and precision. - Assist in regulatory submissions (FDA, EMA, PMDA) by preparing submission-ready datasets and documentation. - Independently troubleshoot and resolve complex programming issues. Qualifications: - Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field. - Minimum of 9 years of experience as a Statistical Programmer in the pharmaceutical, biotechnology, or CRO industry. - Proficiency in SAS programming; familiarity with R or other statistical software is advantageous. - Thorough understanding of CDISC SDTM and ADaM standards. - Experience supporting Phase IIV clinical trials and regulatory submissions. - Strong problem-solving, communication, and organizational abilities. - Capable of working independently and in a team-oriented setting. In this full-time role, you will have the opportunity to work remotely from India. Additionally, you will benefit from paid sick leave and access to the Provident Fund. If you have a minimum of 4 years of experience in SAS programming, this position could be a great fit for you. Apply now and be a part of our dynamic Biometrics team!,