Manager 1, Statistical Programming
HybridGurgaon, Uttar Pradesh, Republic of India
Job Summary
Lead statistical programming activities across multiple clinical studies to ensure timely, high-quality deliverables for regulatory submissions and ad hoc analyses. Develop and maintain CDISC-compliant SDTM and ADaM specifications, oversee SAS program creation for datasets and reports, and contribute to standard macro development and statistical programming standards. Manage CRF annotation, SAP, and TLFs specifications while handling P21 items and eCRT packages for FDA, EMA, and PMDA submissions. Plan deliveries with study teams, mentor junior programmers, and provide technical expertise on complex programming tasks. Work independently within global interdisciplinary teams to support ongoing clinical study requests and regulatory authority guidance.
Required Qualifications
- Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills
- Great knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles) and regulatory submissions (NDA, ANDA etc.)
- Great working knowledge of implementing CDISC standards, Regulatory guidance and TAUG
- Ability to work independently and on global interdisciplinary teams
- Good organizational, interpersonal, and communication skills
- Positive attitude, team player and growth mindset
- Problem solving and innovative skills that demonstrate initiative and motivation
- Hands-on programming as well as people and process management experience
- Demonstrated and applied SAS programming skills
- Minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline
- 8+ years of programming experience in processing clinical trial data in the biotechnology, pharmaceutical, CRO or health care related industry
Desired Qualifications
- Working knowledge of other programming languages such as R, Python etc. is a plus
- SAS certificates a plus
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