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This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Statistical Programmer (ADaM, TLF, SDTM) based in India.
This role sits at the core of clinical data programming within a global life sciences environment, where you will contribute directly to the quality and integrity of clinical trial data used in regulatory submissions and drug development decisions. You will lead complex statistical programming activities across multiple studies, ensuring high-quality deliverables such as datasets, tables, listings, and figures (TLFs). The position requires strong expertise in CDISC standards and hands-on experience across SDTM and ADaM data structures. You will collaborate closely with biostatisticians, study teams, and cross-functional stakeholders to ensure accurate, inspection-ready outputs aligned with regulatory requirements. In addition to technical leadership, you will mentor junior programmers and contribute to process improvements, standards development, and automation initiatives. This is a high-impact role in a fast-paced, global clinical research environment where precision, ownership, and scientific rigor are essential.
Accountabilities:
- Lead the development of statistical programming deliverables, including SDTM and ADaM datasets, TLFs, and derived analysis outputs using SAS and related tools.
- Design and implement programming solutions aligned with statistical analysis plans and sponsor specifications, ensuring accuracy and regulatory compliance.
- Perform validation programming and resolve discrepancies in collaboration with biostatisticians, data managers, and cross-functional teams.
- Ensure adherence to SOPs, industry standards (including CDISC), and regulatory guidelines such as ICH.
- Oversee documentation, quality control, and programming validation processes to maintain inspection-ready study records.
- Manage timelines and deliverables across multiple concurrent studies, proactively identifying risks and proposing mitigation strategies.
- Act as a technical lead for statistical programming activities, guiding team members and reviewing their outputs.
- Participate in study kickoff meetings, sponsor discussions, and bid defense activities as a programming representative.
- Contribute to the development of macros, tools, and standardization initiatives to improve programming efficiency.
- Support mentoring and training of junior programmers and promote best practices in clinical programming.
- Serve as a subject matter expert in CDISC standards, including SDTM, ADaM, and DEFINE.XML compliance requirements.
Requirements:
- 8+ years of experience in Clinical SAS Programming within the pharmaceutical or CRO industry.
- Strong expertise in Base SAS, SAS Macros, SDTM, ADaM, and TLF programming, including specification development.
- Hands-on experience with both safety and efficacy data across clinical trials.
- Solid understanding of CDISC standards and regulatory submission requirements.
- Experience with ISS/ISE analyses is required; exposure to R programming is preferred.
- Oncology therapeutic area experience is a plus.
- Strong analytical mindset with the ability to solve complex data and programming challenges.
- Proven ability to manage multiple studies and deliver under tight timelines.
- Excellent communication skills, both written and verbal, in English.
- Ability to work independently while also collaborating effectively across global teams.
- Immediate availability is preferred.
Benefits:
- Opportunity to work in a global clinical research and life sciences environment
- Exposure to large-scale clinical trials supporting regulatory submissions worldwide
- Leadership role with responsibility for mentoring and technical guidance
- Collaboration with international biostatistics and programming teams
- Career growth opportunities within clinical data science and statistical programming
- Flexible or remote working arrangements depending on project requirements
- Comprehensive health and employee support benefits (as per policy)
- High-impact work contributing to drug development and patient outcomes
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