Senior Statistical Programmer (SDTM, ADaM, TLF) – Hybrid | Hyderabad / Gurugram
Location: Hyderabad / Gurugram, India (Hybrid)
Job Type: Full-Time
Job ID: 25103420
Function: Statistical Programming / Clinical Data Management
Industry: Pharmaceutical / Biopharmaceuticals
About Syneos Health
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By translating clinical, medical affairs, and commercial insights into actionable outcomes, we address modern healthcare and pharmaceutical challenges.
Our Clinical Development model centers on patients and clients, continuously improving processes to simplify collaboration and efficiency. Joining Syneos Health means contributing to high-impact clinical programs and working with a team of innovative problem solvers committed to advancing therapy delivery worldwide.
Role Overview
Syneos Health is seeking a Senior Statistical Programmer with extensive experience in SDTM, ADaM, and TLF development to lead statistical programming activities across multiple clinical studies. This hybrid role is based in Hyderabad or Gurugram and is ideal for candidates with prior experience as a Lead Study Programmer in a pharmaceutical or clinical trial environment.
The role emphasizes high-quality deliverables, regulatory compliance, and mentoring junior programmers, ensuring alignment with global clinical standards.
Key Responsibilities
Develop and validate custom SAS programming code for generating tables, listings, figures (TLFs), and derived datasets in alignment with statistical analysis plans (SAP) and programming specifications.
Ensure outputs meet regulatory and project quality standards; perform validation programming and resolve discrepancies collaboratively with Biostatisticians and project teams.
Maintain organized and inspection-ready project documentation, including QC checks and verification programs.
Manage multiple concurrent projects, prioritize tasks effectively, and adjust workflows to meet timelines and changing project requirements.
Anticipate programming challenges, optimize processes, and develop robust specifications for datasets and outputs with minimal rework.
Lead internal meetings, distribute relevant information, track action items, and support team consensus-building.
Serve as lead statistical programmer, overseeing programming activities of other personnel, reviewing SAPs, mock shells, programming specifications, annotated CRFs, and SAS database designs.
Participate in sponsor meetings, project kickoffs, and bid defenses as a statistical programming representative.
Mentor and guide junior programmers, develop training materials, and provide feedback to enhance team capabilities.
Minimal travel may be required.
Required Qualifications & Experience
Undergraduate or Master’s degree in a scientific, statistical, or life sciences discipline; or equivalent experience in clinical programming.
5+ years of statistical programming experience, including SDTM, ADaM, and TLF generation in clinical trials.
Proven experience as a Lead Study Programmer, managing study-level deliverables.
Strong SAS programming skills and familiarity with clinical trial data standards.
Exposure to R programming is a plus.
Excellent written and verbal communication skills in English.
Core Competencies
Analytical thinking and attention to detail in clinical data programming.
Ability to manage multiple priorities and projects simultaneously.
Strong collaboration skills and ability to work effectively in cross-functional teams.
Mentorship and leadership skills to guide junior programmers.
Commitment to high-quality deliverables and regulatory compliance.
Why Join Syneos Health
Opportunity to contribute to global clinical trials and FDA-/EMA-approved therapies.
Hybrid work model combining Hyderabad and Gurugram offices.
Lead and mentor programming teams while developing technical expertise in SDTM, ADaM, and TLF programming.
Work with a globally recognized biopharmaceutical organization driving innovation in clinical research.
Summary
The Senior Statistical Programmer (SDTM, ADaM, TLF) leads and executes statistical programming activities across multiple clinical studies, ensuring high-quality deliverables and regulatory compliance. The ideal candidate has 5+ years of statistical programming experience, proven SAS expertise, and prior leadership experience in a clinical trial environment.
Gujarat :
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