Senior Principal Statistical Programmer
Location: Hyderabad, Andhra Pradesh, India
Job Type: Full-Time
Company: Merck Group
Overview:
Merck is hiring a Senior Principal Statistical Programmer to lead global clinical trial programming initiatives, contribute to strategic decisions, and mentor junior programmers. This high-impact role blends deep technical expertise in SAS, R, and CDISC standards with project leadership, focusing on innovative and integrated clinical data delivery.
Key Responsibilities:
Act as Lead Statistical Programmer for clinical trials or assets, ensuring quality and timeline adherence
Develop and validate SDTM and ADaM datasets, create specifications, and generate statistical outputs per SAP
Contribute to integrated analyses (e.g., ISS, ISE) and perform ad-hoc programming tasks as needed
Lead cross-functional collaborations in asset-level programming strategies and initiatives
Support innovation through automation and technical advancements (e.g., R, Shiny)
Guide and train junior statistical programmers, fostering team development and knowledge sharing
Ensure compliance with CDISC standards (e.g., Define.xml, reviewer guides) and regulatory submission best practices
Qualifications & Experience:
Education: Bachelor’s or Master’s degree in Mathematics, Statistics, Computer Science, or related discipline
Experience: Minimum 9 years in statistical programming within pharma, biotech, or CRO (international experience is a plus)
Technical Skills:
Advanced proficiency in SAS and R
Strong knowledge of CDISC SDTM and ADaM standards
Hands-on experience with Define.xml, reviewer’s guides, and clinical e-submission processes
Soft Skills:
Strong leadership, project management, and problem-solving abilities
Effective communicator, collaborator, and mentor across global teams
Estimated Salary: ₹35–45 LPA (based on seniority, location, and industry benchmarks)
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