Senior/ Principal Statistical Programmer

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.

Accountabilities:: 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.

Requirements:

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.

Benefits:

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.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1