Job Summary
Syneos Health is seeking an experienced Senior Statistical Programmer for its Pune location. This role requires strong proficiency in SAS programming, SDTM, ADAM, and TLFs within a clinical trial environment. The candidate will work on developing and validating clinical trial datasets, generating outputs per the Statistical Analysis Plan (SAP), and ensuring all programming activities meet quality standards and regulatory guidelines. This is a great opportunity for clinical programmers to contribute to global drug development projects.
Key Responsibilities
Develop custom programming code using SAS or other tools for generating summary tables, listings, graphs, and derived datasets.
Validate programming outputs and resolve discrepancies with Biostatisticians and project teams.
Maintain detailed project documentation ensuring inspection readiness.
Create specifications for datasets and outputs based on statistical and sponsor requirements.
Lead programming activities for multiple projects and coordinate with internal teams.
Participate in sponsor, kickoff, and bid defense meetings.
Contribute to training and mentoring of junior programming staff.
Ensure timely delivery of all programming deliverables.
Follow SOPs, Work Instructions, and regulatory guidelines (ICH-GCP, GVP).
Perform other related duties as assigned.
Required Skills & Qualifications
Minimum 5+ years of experience in Clinical Statistical Programming.
Bachelor’s degree in Statistics, Computer Science, or relevant discipline (or equivalent experience).
Strong expertise in SAS programming within clinical trials.
Proficiency in SDTM, ADAM dataset creation, and TLF generation.
Excellent verbal and written communication skills in English.
Ability to manage multiple priorities and deliver high-quality outputs.
Knowledge of global regulatory guidelines (ICH, GCP).
Strong attention to detail and problem-solving abilities.
Perks & Benefits
Competitive salary package (Range not specified).
Opportunities for career development and internal progression.
Technical and therapeutic area training.
Supportive and inclusive company culture (Total Self culture).
Global project exposure across 110 countries.
Employee recognition and Total Rewards program.
Company Description
Syneos Health is a global leader in biopharmaceutical solutions, offering integrated clinical and commercial services. With presence in over 110 countries, Syneos Health has contributed to 94% of all novel FDA drug approvals, enabling faster and more efficient development of therapies worldwide.
Work Mode
Hybrid (Pune, India)
Call-to-Action
Advance your clinical programming career with Syneos Health. Apply now to be part of a global team that drives innovation in drug development.
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