Sr Statistical Programmer – Syneos Health (Pune, India)
Job Summary
Syneos Health, a leading biopharmaceutical solutions organization, is hiring an experienced Sr Statistical Programmer in Pune. The ideal candidate will have 5–8 years of SAS programming experience, specializing in SDTM, ADaM datasets, and clinical trial data handling. This is a great opportunity to contribute to global regulatory submissions and drug development processes.
Key Responsibilities
Develop and validate SDTM/ADaM datasets, TFLs, and define.XML.
Support safety and efficacy analyses.
Perform validation programming and resolve discrepancies with team members.
Generate custom programming code using SAS or other tools for clinical data analysis.
Manage multiple project timelines and adapt to shifting priorities.
Provide feedback on project documentation such as SAP, mock shells, and annotated CRFs.
Lead statistical programming activities and direct junior programmers.
Contribute to training and mentoring new programming personnel.
Participate in sponsor meetings and provide statistical programming expertise.
Transfer deliverables and ensure inspection readiness with complete documentation.
Required Skills & Qualifications
5–8 years of experience in SAS programming within clinical trials.
Strong knowledge of SDTM, ADaM, TFLs, define.XML, ADRG/SDRG.
Proficient in e-submission processes for regulatory bodies.
Graduate/Postgraduate degree in a scientific/statistical discipline (or equivalent experience).
Excellent communication skills in English.
Ability to handle multiple projects and deliver high-quality outputs.
Perks & Benefits
Career development and progression programs.
Technical and therapeutic area training.
Peer recognition and total rewards programs.
Inclusive and diverse work culture through the Total Self initiative.
Opportunities to contribute to global drug development and regulatory submissions.
Company Description
Syneos Health is a global biopharmaceutical solutions organization that partners with healthcare innovators to improve patient outcomes. With operations in over 110 countries, Syneos Health is known for its strong focus on clinical development and regulatory compliance, driving innovation across the drug lifecycle.
Work Mode
On-site – Pune, MH, India
Call-to-Action
Ready to elevate your career in statistical programming? Apply now to become a key contributor at Syneos Health and be part of transforming global healthcare solutions.
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