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Senior Principal Statistical Programmer

9+ years
₹35–45 LPA
10 July 28, 2025
Job Description
Job Type: Full Time Education: Bsc/Msc Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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)