Principal Statistical Programmer – ADaM/TLF (Oncology) – Remote, India
Location: Remote (India)
Job Type: Full-Time
Job ID: 25104090
Updated: December 29, 2025
About Syneos Health
Syneos Health is a leading global biopharmaceutical solutions organization, driving accelerated clinical and commercial outcomes. We combine scientific, clinical, and technical expertise to help clients achieve faster, safer, and more effective drug development.
With over 29,000 employees across 110 countries, Syneos Health empowers professionals to innovate, collaborate, and deliver measurable impact in an inclusive and supportive work environment.
Position Overview
We are seeking a Principal Statistical Programmer – ADaM/TLF (Oncology) to lead complex oncology programming projects and act as a subject matter expert in CDISC standards, ADaM datasets, and TLF generation. This role requires advanced SAS programming skills, expertise in oncology trials, and strong leadership and mentoring capabilities.
The Principal Statistical Programmer ensures high-quality, regulatory-compliant deliverables and provides guidance to junior programmers while actively contributing to standardization and process improvement initiatives.
Key Responsibilities
Statistical Programming & Deliverables:
Develop custom SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) as per statistical analysis plans.
Ensure outputs meet regulatory, quality, and project requirements; perform validation programming and resolve discrepancies.
Maintain organized, complete, and inspection-ready documentation, testing, and verification materials.
Lead ADaM/TLF programming projects, ensuring timely delivery across multiple concurrent assignments.
Participate in regulatory submissions, including DEFINE.XML and other compliance documentation.
Leadership & Mentorship:
Act as lead programmer, directing activities of junior programmers and providing constructive feedback.
Mentor and train team members on clinical trial processes, CDISC standards, and regulatory requirements.
Conduct internal meetings effectively, track action items, and facilitate collaboration across cross-functional teams.
Technical Expertise & Compliance:
Serve as a subject matter expert for CDISC standards (SDTM, ADaM) and industry best practices.
Conduct compliance reviews for deliverables, ensuring alignment with regulatory submissions.
Stay updated on CDISC and industry standards; provide guidance and training to the Biostatistics department.
Develop programming tools and macros to enhance efficiency and standardization.
Collaboration & Project Management:
Work closely with biostatisticians, data managers, and project teams to address technical programming challenges.
Participate in sponsor meetings, project kick-offs, and bid defenses as programming representative.
Provide proactive risk mitigation plans and communicate status updates to management.
Required Qualifications
Education & Experience:
Undergraduate degree in Statistics, Life Sciences, Pharmacy, or related field; equivalent experience considered.
Extensive SAS programming experience in clinical trials, specifically with oncology studies.
Proven expertise in CDISC standards (SDTM/ADaM), TLF programming, and regulatory submissions.
Experience leading multiple complex/global projects and mentoring programming teams.
Technical Skills:
Proficiency in SAS, statistical programming, and data management best practices.
Strong knowledge of clinical trial processes and oncology therapeutic area requirements.
Familiarity with submission requirements for regulatory agencies (FDA, EMA).
Excellent documentation, validation, and version control practices.
Leadership & Communication:
Strong mentoring, leadership, and collaboration skills.
Excellent written and verbal communication in English.
Ability to work independently and within cross-functional teams in a fast-paced environment.
Why Join Syneos Health
Lead advanced oncology statistical programming projects in a global, remote-friendly environment.
Influence the quality, compliance, and efficiency of clinical trial deliverables.
Mentor and develop the next generation of statistical programmers.
Contribute to innovative solutions that accelerate oncology drug development and patient impact.
Additional Information
Tasks and responsibilities may evolve based on business needs.
Minimal travel may be required.
Syneos Health is an equal opportunity employer and provides reasonable accommodations to support employee success.
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