11 Sdtm Jobs nearby Vijayawada

Role Overview: You are an experienced Lead Statistical Programmer responsible for overseeing programming activities for clinical trials, regulatory submissions, and integrated analyses. Your role involves leading a team, ensuring high-quality deliverables, and developing efficient programming standards to support drug development. Key Responsibilities: - Lead statistical programming activities for a compound or therapeutic area. - Manage, mentor, and guide a team of statistical programmers. - Create and validate analysis data sets (ADaM), tables, listings, and figures (TFLs) following CDISC standards. - Develop and validate Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) reports. - Ensure accuracy and consistency across clinical studies and integrated data. - Develop, test, and implement reusable standard programs and SAS macros to automate routine tasks. - Prepare reviewer guides, data definition documents, and other materials for regulatory filings. - Collaborate with cross-functional teams including Statisticians, Clinical Data Management, Medical Writing, Regulatory, and Clinical Operations. - Accurately estimate programming efforts and ensure timely project delivery. Qualifications Required: - Strong proficiency in SAS programming; experience with R preferred. - In-depth knowledge of CDISC standards (ADaM, SDTM). - Experience with regulatory submissions (FDA, EMA) and clinical study lifecycle. - Knowledge of therapeutic areas such as Oncology, Immunology, Neuroscience. - Strong communication and leadership skills to guide teams and manage stakeholders. - Ability to handle multiple priorities and deliver high-quality results under deadlines.,

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.,

Role Overview: As a Senior Clinical Data Programmer, your core responsibility is to understand complex business requirements and identify strategic opportunities to drive efficiency and value through data. You will leverage advanced programming languages, scripts, and software tools to perform sophisticated data extraction, transformation, and validation, ensuring the highest standards of data integrity and consistency across critical projects. Key Responsibilities: - Architect and maintain complex programs, ensuring robust data integrity and accuracy. - Create advanced programs for generating detailed reports and summaries of clinical trial data. - Design and implement advanced software to ensure data handling and reporting meet stringent regulatory standards. - Ensure data quality and integrity through rigorous validation and quality control processes. - Identify, analyze, and resolve complex database issues to ensure seamless operation and data flow. - Generate complex reports by finding, selecting, acquiring, and ingesting data sources utilizing established tools and methods. - Develop sophisticated automation tools to streamline repetitive tasks, improving efficiency and reducing errors. - Perform code reviews and introduce best practices. - Support data setup (eCRF) design if needed. - Seek specialist security knowledge or advice when required to support your work or that of immediate colleagues. Qualifications Required: - Knowledge of clinical vocabulary and healthcare data standards. - Demonstrable understanding of relevant ICH-GCP Guidelines, local regulatory requirements, and SOPs and study-specific procedures. - Significant demonstrable knowledge and understanding of clinical trial data systems, regulatory requirements, and industry standards - CDISC (CDASH/SDTM/ADaM) mapping/specs/conversion/domains/dataset desirable. - Understanding of clinical trial protocols and case report forms. - Comprehensive knowledge of Good Clinical Practice: In-depth understanding of clinical trial design and the overall drug development process. - Strong advanced analytical and problem-solving skills to address complex data-related issues. - Strong logical reasoning and structured problem-solving skills. - Ability to approach complex problems methodically and develop effective solutions in a fast-paced, time-sensitive, and dynamic environment. - Advanced analytical thinking, attention to detail: Ensure high-quality results with a focus on accuracy and precision. - Robust time management and prioritization skills to meet objectives and timelines. - Proven ability to work collaboratively within a matrix team environment. - Communicate fluently, orally and in writing, and present complex information to both technical and non-technical audiences. - Ability to swiftly understand new technologies and processes - quickly adapt to and integrate new technologies and methodologies with a knowledge-sharing approach. - Ability to manage multiple and varied tasks: enthusiastically handle multiple tasks and prioritize workload with meticulous attention to detail. - Maintain an awareness of developing practices and their application and take responsibility for driving your own development. - Demonstrated ability to apply critical thinking to complex problems and tasks. - Proactive participation in skills improvement. - Demonstrated evidence of accountability relative to key accountabilities in the job description.,

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.,

Role Overview: As a Statistical Programmer at Statistics & Data Corporation (SDC), your primary responsibility will be to provide statistical programming support for clinical trials. This includes generating and validating analysis datasets, tables, listings, and figures for clinical trials, creating SDTM mapping and datasets, and maintaining the infrastructure for project files of SAS datasets and SAS code. You will collaborate with Data Management on data set creations/transfers, integrity checks, and quality audits, and act as a liaison between clinical subcommittees and project teams as needed. Key Responsibilities: - Performing statistical programming for clinical trial analysis and reporting on large-scale, complex projects - Applying appropriate statistical methods for data analysis and providing expertise to project teams - Leading the design and development of SAS macros and utilities to expedite programming activities - Generating tables, listings, and figures per protocol and client requests - Reviewing reports for compliance with CDISC and FDA guidelines - Developing documentation and study data reviewers guides - Managing programming timelines, budgets, and client expectations - Mentoring junior statistical programmers and ensuring compliance with standard procedures and sponsor requirements Qualifications Required: - Strong analytical skills - Proficiency in SAS programming (SAS/Base, SAS/Stat, SAS Macros, and SAS/Graph) - Problem-solving abilities and the capability to work independently - Excellent knowledge of statistical programming - Ability to communicate technical concepts clearly - Familiarity with clinical trial design and regulatory guidelines (Note: Additional Company Details are omitted as they are not present in the provided job description.),

Role Overview: As a Principal Biostatistician at Sanofi Business Operations, you will collaborate with Medical Affairs biostatisticians, programmers, and internal biostatistics and programming personnel to implement statistical analysis plans (SAP) and programming specifications. Your main responsibility will be to provide QC done data packages for use in publications and to investigate the natural history of diseases using clinical trials and registries. You will also ensure SOPs are followed, communicate effectively, meet timelines, and maintain quality metrics. Additionally, you will collaborate with local and global teams to support stakeholders and provide end-to-end solutions for various therapeutic areas. Key Responsibilities: - Develop and maintain effective relationships with stakeholders and local team members to generate statistical data outputs. - Conduct post-hoc or ad-hoc statistical analyses of clinical trial and observational data. - Design, develop, test, and implement statistical programming using software packages like SAS. - Produce well-documented data packages including tables, listings, and figures. - Work with the Team Lead to develop project QC plans, timelines, and KPIs. - Review biomedical and clinical research literature related to projects. - Participate in project governance meetings and present topics in internal lecture series. - Use advanced analytical methods to provide dashboards to stakeholders. - Collaborate with Global Medical Affairs team to identify statistical analysis needs and develop deliverables. Qualifications Required: - Master's degree with 8 years of experience (M.Sc.) or Ph.D. in biostatistics, statistics, or epidemiology preferred, with 4 years of experience. - Soft skills: Stakeholder management, ability to manage timelines, work independently and within a team, proficiency in statistical methods, and ability to manage multiple priorities. - Technical skills: Advanced SAS programming skills, SDTM & ADaM (CDISC), and proficiency in statistical computing software. - Education: Master of Science degree or equivalent in Statistics/Ph.D. in biostatistics, statistics, or epidemiology. - Languages: Excellent written and spoken English language skills. About the Company: Sanofi Business Operations is an internal resource organization based in India that centralizes processes to support various functions within Sanofi globally. The organization aims to be a strategic partner for delivering tactical solutions to Medical, HEVA, and Commercial organizations within Sanofi. It provides opportunities for professionals to collaborate on impactful projects and contribute to the advancement of healthcare. Pursue progress, discover extraordinary with Sanofi Business Operations. Join a diverse team of individuals united by the desire to make miracles happen in the pharmaceutical industry. Check out Sanofi's Diversity, Equity, and Inclusion actions on sanofi.com to learn more about our commitment to creating a better future through innovation and inclusivity.,

Role Overview: As a Senior Statistical Programmer, you will be providing advanced technical expertise to develop process methodology for the department to meet internal and external client needs. Your role will involve planning and coordinating the development of integrated programming solutions to cater to the full spectrum of statistical programming needs. Your leadership and technical expertise will be crucial in providing internal consulting services, including specifications and user needs analysis for complex projects or client requirements. Key Responsibilities: - Perform, plan, coordinate, and implement programming, testing, and documentation of statistical programs for creating statistical tables, figures, and listings. - Develop analysis datasets and transfer files for both internal and external clients. - Conduct programming quality control checks for source data and report data issues periodically. - Interpret project requirements and develop programming specifications for complex studies. - Collaborate with internal and external clients to bring project solutions to the Statistical Programming team. - Act as a technical team lead for single complex studies or a group of studies. - Communicate effectively with statisticians and clinical team members to ensure understanding of requirements and project timelines. - Estimate programming scope, manage resource assignments, and communicate project status to stakeholders. - Promote the use of established standards, SOPs, and best practices. - Provide training and mentoring to team members and department staff. Qualifications: - Master's or Bachelor's Degree in Mathematics, Computer Science, or Statistics. - 7+ years of relevant experience. - Equivalent combination of education, training, and experience in lieu of a degree. - Advanced knowledge of statistics, programming, and clinical drug development processes. - Proficiency in computing applications such as Base SAS, SAS Graph, and SAS Macro Language. - Strong organizational, interpersonal, leadership, and communication skills. - Attention to detail, aptitude for mathematical calculations, and problem-solving abilities. - Familiarity with relevant Data Standards like CDISC, ADaM, and SDTM. - Ability to establish and maintain effective working relationships with colleagues, managers, and clients.,

As an experienced statistical programmer looking to take the next step in your career, you have the opportunity to join a global clinical programming team in India. In this role, you will work with clinical trial data and CDISC standards, contributing to high-quality analysis that drives important decisions in global clinical research. **Role Overview:** You will use your SAS programming expertise to produce and validate high-quality datasets and outputs, working with SDTM, ADaM, and tools such as Pinnacle21. Additionally, you will take responsibility for project issues, provide guidance to junior programmers, and contribute to study-level programming activities. **Key Responsibilities:** - Produce and validate high-quality datasets and outputs using SAS programming - Work with SDTM, ADaM, and tools like Pinnacle21 - Stay alert to project issues, communicate early, and ensure project smoothness - Provide guidance and support to junior programmers, reviewing their work and helping them build confidence - Contribute to study-level programming activities and take on lead responsibilities when appropriate - Communicate effectively with cross-functional partners and collaborate in a hybrid setup **Qualifications Required:** - Minimally qualified to MSc level in Statistics or a Mathematics based degree with a high proportion of statistics content - Relevant experience within the pharmaceutical industry and/or medical sector desired - Strong years of hands-on experience in statistical programming within clinical research or a similar data-driven environment - Strong SAS programming background with experience in writing, debugging, and validating complex code - Practical experience working with CDISC standards, specifically SDTM and ADaM datasets, and familiarity using Pinnacle21 for compliance checks - Experience mentoring or supporting junior programmers, providing guidance and reviewing work **Additional Details of the Company:** Quanticate is a world-leading data-focused CRO that collaborates with customers on complex clinical trials requiring a high level of statistical programming, statistics, and data management input. They encourage career development by providing membership to professional societies, involvement in activities and committees, and offering opportunities to work on challenging problems to ultimately develop clinical therapies that matter. If you are looking to advance your technical skillset, grow into lead and mentoring roles, and be part of a workplace culture that values initiative and continuous improvement, this role can be a strong foundation for a rewarding career in data science, healthcare, and innovation.,

As a Statistical Programmer at Statistics & Data Corporation (SDC), a reputable contract research organization based in Arizona, you will be responsible for providing statistical programming support for clinical trials. Your primary role will involve producing statistical analyses, generating and validating analysis datasets, tables, listings, and figures for clinical trials. - Create SDTM mapping and datasets - Develop and maintain project files of SAS datasets and SAS code - Support Data Management in various data-related tasks - Act as a liaison between clinical subcommittees and project teams as needed - Oversee statistical programming activities for medium to large-scale projects - Apply appropriate statistical methods for data analysis - Provide statistical programming expertise to project teams - Review the Statistical Analysis Plan - Lead the development of SAS macros and utilities - Conduct internal training sessions - Generate tables, listings, and figures as per protocol requirements - Participate in statistical program validation activities - Develop SDTM and ADaM datasets - Ensure compliance with CDISC and FDA guidelines - Develop define.xml and study data reviewer's guides - Communicate effectively with project teams and management To qualify for this role, you should possess: - Bachelor's degree in computer science, statistics, or a related scientific field - At least six years of relevant professional experience - Certification in SAS Base, Advance, and Clinical Trials is preferred At SDC, we are committed to the growth and development of our employees, providing a flexible work schedule, engaging work culture, and career advancement opportunities. Our company culture is centered around core values such as Energy, Integrity, Engagement, and Innovation. Join our team and be part of a dynamic and innovative organization that is dedicated to supporting both our clients and employees in this ever-evolving industry.,

As an Associate Director Statistical Programmer, you will have the opportunity to work with advanced technical solutions such as R, Shiny, and SAS, allowing you to lead asset teams and mentor staff effectively. In this role, you will contribute to global assets across a variety of therapeutic areas, shaping strategic decisions in statistical programming. - Lead one or more asset programming teams as the Lead Statistical Programmer, ensuring that asset and trial delivery aligns with established timelines and quality standards. - Perform programming activities at both trial and asset levels, including the development of SDTM and ADaM datasets and the creation of specifications. - Develop and validate analytical outputs in accordance with the Statistical Analysis Plan and create datasets for integrated analyses like ISS or ISE. - Create submission-ready data packages, including documentation such as define.xml, cSDRG, and ADRG. - Execute ad-hoc programming activities based on internal and external requests. - Actively contribute to statistical programming initiatives, support process improvements and innovation, and provide expert advice, guidance, and training to trial and asset teams. Qualifications Required: - BSc or MSc (in a numerate discipline preferably in Mathematics, Statistics, or Computer Science). - Proven success in a Statistical Programming role within clinical development at a pharmaceutical or biotech company, or at a CRO, equivalent to a minimum of 10 years directly relevant experience. Experience in an international environment is a plus. - Advanced skills in R and SAS. - Full familiarity with CDISC SDTM and ADaM standards (including specifications, Define.xml, and reviewers guide) and underlying concepts. - Strong understanding of processes related to clinical development programs. Experience in leading e-submission processes is beneficial. - Demonstrated ability to manage assets effectively, ensuring timely delivery and quality outcomes. - Ability to provide solutions for complex programming challenges and evaluate alternatives to identify optimal solutions. Working at our company means being part of a diverse, inclusive, and flexible working culture that presents great opportunities for personal development and career advancement across the globe. We value all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team! As an Associate Director Statistical Programmer, you will have the opportunity to work with advanced technical solutions such as R, Shiny, and SAS, allowing you to lead asset teams and mentor staff effectively. In this role, you will contribute to global assets across a variety of therapeutic areas, shaping strategic decisions in statistical programming. - Lead one or more asset programming teams as the Lead Statistical Programmer, ensuring that asset and trial delivery aligns with established timelines and quality standards. - Perform programming activities at both trial and asset levels, including the development of SDTM and ADaM datasets and the creation of specifications. - Develop and validate analytical outputs in accordance with the Statistical Analysis Plan and create datasets for integrated analyses like ISS or ISE. - Create submission-ready data packages, including documentation such as define.xml, cSDRG, and ADRG. - Execute ad-hoc programming activities based on internal and external requests. - Actively contribute to statistical programming initiatives, support process improvements and innovation, and provide expert advice, guidance, and training to trial and asset teams. Qualifications Required: - BSc or MSc (in a numerate discipline preferably in Mathematics, Statistics, or Computer Science). - Proven success in a Statistical Programming role within clinical development at a pharmaceutical or biotech company, or at a CRO, equivalent to a minimum of 10 years directly relevant experience. Experience in an international environment is a plus. - Advanced skills in R and SAS. - Full familiarity with CDISC SDTM and ADaM standards (including specifications, Define.xml, and reviewers guide) and underlying concepts. - Strong understanding of processes related to clinical development programs. Experience in leading e-submission processes is beneficial. - Demonstrated ability to manage assets effectively, ensuring timely delivery and quality outcomes. - Ability to provide solutions for complex programming challenges and evaluate alternatives to identify optimal solutions. Working at our company means being part of a diverse, inclusive, and flexible working culture that presents great opportunities for personal development and career advancement across the globe. We value all dimensions of dive

Role Overview: As a Clinical Data Operations Specialist at Novartis Healthcare Private Limited, your role is crucial in managing data operations for use cases and demand deliverables within the Clinical Pipeline team. You will be responsible for overseeing the timely and professional maintenance of the clinical data warehouse, ensuring cost-effectiveness, quality, and adherence to timelines. Your involvement will extend to developing engaging training modules for Clinical Data Mapper onboarding, utilizing AI-based technology to simplify processes and enhance training delivery. Key Responsibilities: - Provide data mapping leadership across assigned use cases. - Manage task allocation for Clinical Data Mapper staff. - Resolve conflicts in data flows. - Ensure data compliance through quality checks and validation processes. - Maintain consistency in data mappings and build data dictionaries. - Conduct data quality assessments. - Collaborate with Data Scientists and contribute to process improvements. - Work closely with the Data Engineering team for advanced data mapping requirements. Qualification Required: - Minimum of 5 years of experience working with clinical data. - Strong knowledge of CDISC standards (SDTM/ADaM). - Proficiency in Clinical Data Lifecycle. - Skills in clinical data management, governance, integrity, operations, quality, and privacy. - Expertise in databases, project management, and SAS/SQL. - Familiarity with Python and Artificial Intelligence. - Cross-cultural experience, functional breadth, and agile way of working. Additional Company Details: Joining Novartis offers you the opportunity to be part of a community dedicated to making a difference in patients" lives through innovative science. By collaborating with a team of smart and passionate individuals, you can contribute to breakthroughs that positively impact healthcare. Novartis is committed to providing accessibility and accommodation for individuals with disabilities during the recruitment process to build an inclusive work environment representing the diversity of the patients and communities served.,