Senior/ Principal Statistical Programmer in India at Jobgether
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Job Description
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior/ Principal Statistical Programmer based in India.
This role offers the opportunity to contribute to impactful clinical research programs through advanced statistical programming and data-driven insights. You will support the development, validation, and delivery of regulatory-quality clinical outputs while working with complex healthcare datasets. The position requires strong expertise in R and SAS, along with experience in CDISC standards and clinical trial programming. You will collaborate with cross-functional teams to deliver accurate and compliant statistical deliverables that support critical decision-making. This is a remote, long-term contract opportunity suited for experienced professionals who enjoy solving complex data challenges. Your expertise will directly contribute to advancing evidence-based healthcare solutions.
The Senior/ Principal Statistical Programmer will be responsible for delivering high-quality statistical programming solutions across clinical development projects. The role involves designing, developing, validating, and maintaining programming workflows that support regulatory submissions and clinical data analysis.
- Perform end-to-end statistical programming activities for ADaM datasets, Tables, Listings, and Figures (TLFs).
- Support regulatory deliverables, including Integrated Summary of Safety (ISS), Integrated Summary of Effectiveness (ISE), submissions, and regulatory queries.
- Develop, validate, and maintain CDISC-compliant SDTM and ADaM datasets according to industry standards.
- Create and enhance reusable programming utilities, macros, functions, and automation solutions to improve efficiency.
- Develop and apply metadata specifications, programming specifications, and data derivation logic.
- Support analysis using clinical trial data, historical trial data, Real-World Data (RWD), biomarker data, and External Control Arms.
- Build and validate analysis cohorts, including datasets used for advanced clinical and real-world evidence studies.
- Apply statistical programming techniques for complex analyses, including survival analysis and propensity score methodologies.
- Collaborate with clinical, statistical, data management, and regulatory teams to ensure accurate and compliant outputs.
The ideal candidate is an experienced statistical programmer with a strong background in clinical research programming, regulatory submissions, and modern analytical approaches. You should have proven expertise in R and SAS, strong knowledge of CDISC standards, and the ability to independently manage complex programming activities.
- 6–10+ years of experience in statistical programming within the clinical research domain.
- Strong hands-on programming expertise in R, with at least 1–3+ years of practical experience.
- Solid SAS programming experience with exposure to clinical trial programming workflows.
- Experience developing clinical datasets, TLFs, and regulatory submission deliverables.
- Strong understanding and practical experience with CDISC SDTM and ADaM standards.
- Knowledge of SQL and/or Python is an advantage.
- Experience working with Real-World Data (RWD), Real-World Evidence (RWE), biomarker data, and external control datasets is preferred.
- Experience in therapeutic areas such as oncology, respiratory, or immunology is highly desirable.
- Familiarity with EHR and claims-based datasets is a plus.
- Experience with survival analysis and propensity score methods is beneficial.
- Strong attention to detail, analytical thinking, and ability to work independently in a remote environment.
- Excellent communication and collaboration skills when working with multidisciplinary teams.
- Fully remote work opportunity.
- Long-term contract engagement with opportunities to contribute to meaningful clinical research projects.
- Competitive salary package based on experience and expertise.
- Opportunity to work with advanced statistical programming methodologies and healthcare datasets.
- Exposure to global clinical development and regulatory submission processes.
- Flexible work environment supporting experienced professionals.