Job Title:
Statistical Programmer II
Location:
Hyderabad, India (Hybrid)
Experience Required:
3 – 4.5 years
About Syneos Health®
Syneos Health® is a fully integrated biopharmaceutical solutions organization, built to accelerate customer success by translating clinical, medical affairs, and commercial insights into outcomes.
29,000 employees across 110 countries
Partnered in 94% of all Novel FDA Approved Drugs (last 5 years)
Worked on 95% of EMA Authorized Products and 200+ studies across 73,000 sites and 675,000+ trial patients
Our Culture:
Total Self Culture – authenticity, inclusivity, and belonging
Career growth and progression opportunities
Supportive line management, technical/therapeutic training, peer recognition, and rewards
Commitment to diversity, equity, and inclusion
Key Responsibilities
Perform statistical programming for clinical trials using SAS (Base SAS, SAS Macros, SAS SQL)
Develop and validate ADaM datasets in compliance with CDISC standards for regulatory submissions
Generate Tables, Listings, and Figures (TFLs) for both safety and efficacy endpoints
Collaborate with cross-functional teams to deliver high-quality statistical outputs
Support submission activities by ensuring datasets and outputs meet regulatory requirements
Good to Have (Preferred Skills)
Experience in programming patient narratives
Exposure to ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy) preparation
Knowledge of PK/PD analysis (non-compartmental analysis, support for modeling activities)
Therapeutic area experience in Oncology, Neuroscience, and Immunology
Qualifications & Expertise
Advanced proficiency in SAS programming (Base SAS, Macros, SQL)
Hands-on experience with ADaM specifications and dataset development
Strong knowledge of CDISC standards
Proven track record in generating TFLs (safety & efficacy endpoints)
Additional Information
Tasks and responsibilities may evolve as per business needs.
Equivalent experience/skills/education will be considered.
Syneos Health is committed to equal opportunity employment and providing reasonable accommodations under the Americans with Disabilities Act (ADA).
Why Join Us
At Syneos Health, Work Here Matters Everywhere. We empower employees to challenge the status quo, collaborate as problem solvers, and accelerate the delivery of therapies that change lives.
How to Apply
Apply directly via Syneos Health Careers or join our Talent Network to stay updated on opportunities.
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