Sr Statistical Programmer(ADaM, TLF & SDTM)

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Sr Statistical Programmer (ADaM, TLF & SDTM) in India.

This role is a senior-level opportunity within clinical programming, where you will play a key part in transforming complex clinical trial data into high-quality, submission-ready outputs that support global regulatory approvals. You will work across multiple studies, ensuring the accuracy and consistency of SDTM and ADaM datasets, as well as Tables, Listings, and Figures (TLFs). Operating in a fast-paced, global clinical development environment, you will collaborate closely with biostatisticians, study teams, and cross-functional stakeholders. The role also involves leading programming efforts, mentoring junior team members, and ensuring adherence to regulatory standards and best practices. You will contribute directly to oncology and other therapeutic area studies, helping drive the successful delivery of critical clinical evidence. This is a high-impact position combining technical excellence, leadership, and regulatory rigor.

Accountabilities

In this role, you will lead and execute statistical programming activities across clinical studies, ensuring the delivery of high-quality, regulatory-compliant datasets and outputs. You will also provide technical leadership, guide junior programmers, and ensure alignment with study timelines, standards, and regulatory requirements.

• Develop and validate SAS programs for SDTM and ADaM datasets, as well as TLF outputs based on SAP and specifications
• Lead statistical programming activities across multiple clinical studies, ensuring timely and high-quality deliverables
• Create and maintain programming specifications, dataset documentation, and analysis-ready structures
• Perform validation programming and resolve discrepancies in collaboration with biostatisticians and study teams
• Ensure compliance with CDISC standards, SOPs, and regulatory guidelines (ICH and global authorities)
• Support ISS/ISE deliverables and contribute to regulatory submissions and inspection readiness packages
• Review CRFs, SAPs, mock shells, and technical documentation to ensure programming accuracy
• Lead and mentor junior programmers, providing guidance, training, and code reviews
• Participate in sponsor meetings, bid defenses, and cross-functional project discussions
• Manage priorities across multiple studies while meeting strict timelines and quality expectations

Requirements

The ideal candidate brings strong clinical SAS programming expertise with deep experience in SDTM, ADaM, and TLF development. You are confident working in global teams, managing multiple priorities, and leading programming efforts in complex clinical environments.

• 5+ years of experience in clinical SAS programming within pharma, biotech, or CRO environments
• Strong expertise in Base SAS, SAS Macros, ADaM, and TLF programming
• Solid understanding of SDTM and CDISC standards, including specification development
• Hands-on experience in safety and efficacy outputs across clinical studies
• Experience in oncology studies and exposure to ISS/ISE deliverables
• Familiarity with regulatory guidelines and submission requirements (FDA, EMA, ICH)
• Experience with R programming is a plus
• Strong analytical, problem-solving, and documentation skills
• Excellent communication skills in English (written and verbal)
• Ability to work independently and lead programming activities across multiple studies
• Immediate availability is preferred

Benefits

• Competitive compensation aligned with experience and expertise
• Health and wellness benefits supporting physical and mental well-being
• Opportunities to work on global, high-impact clinical development programs
• Career development, training, and mentoring opportunities
• Exposure to oncology and complex therapeutic area studies
• Collaborative, inclusive, and globally connected work environment
• Flexible work arrangements depending on project requirements

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