Senior Manager, Statistical Programming
HybridGurgaon, Uttar Pradesh, Republic of India
Job Summary
Lead statistical programming activities across multiple studies to ensure timely, high-quality deliverables for clinical studies, regulatory submissions, and ad hoc analyses. Develop and maintain programming documentation, including CDISC SDTM and ADaM specifications, while overseeing SAS program creation for datasets and reports. Contribute to standard macro development and establish statistical programming standards. Manage and mentor new hires and junior programmers, and participate in CRF annotation and TLFs specification reviews. Handle P21 items and eCRT packages for FDA/EMA/PMDA submissions, supporting global regulatory authority requirements. Plan and complete deliveries with the study team and programming lead while contributing to department goals and SOPs.
Required Qualifications
- Proficiency in SAS programming skills in a clinical data environment
- Excellent analytical skills
- Excellent knowledge of pharmaceutical clinical development
- Understanding of statistical concepts, techniques, and clinical trial principles
- Understanding of regulatory submissions (NDA, ANDA etc.)
- Excellent working knowledge of implementing CDISC standards
- Knowledge of Regulatory guidance and TAUG
- Ability to work independently
- Ability to work on global interdisciplinary teams
- Good organizational skills
- Good interpersonal skills
- Good communication skills
- Positive attitude
- Team player mindset
- Growth mindset
- Problem solving skills
- Innovative skills
- Demonstrated initiative
- Demonstrated motivation
- Hands-on programming experience
- People management experience
- Process management experience
- Minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline
- 12+ years of programming experience in processing clinical trial data
- Experience in the biotechnology, pharmaceutical, CRO or health care related industry
Desired Qualifications
- Working knowledge of other programming languages such as R, Python etc.
- SAS certificates
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