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Senior Principal Statistical Programmer

9 years years
Not Disclosed
10 Aug. 30, 2025
Job Description
Job Type: Full Time Education: Bachelor’s or Master’s degree in a numerate field (e.g., Mathematics, Statistics, Computer Science). 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

🧪 Job Title:

Senior Principal Statistical Programmer

🆔 Job ID:

284489

📍 Location:

Hyderabad, Andhra Pradesh, India

🕒 Job Type:

Full-time


🌍 About Merck:

At Merck, we're united by curiosity and driven by a mission to create, improve, and prolong lives through science and technology. Across our Healthcare, Life Science, and Electronics sectors, we foster a culture that thrives on diversity, innovation, and global collaboration.

In Healthcare, our goal is clear: help patients at every stage of life by developing breakthrough medicines and intelligent technologies in areas like Oncology, Neurology, and Fertility.


🎯 Role Overview:

As a Senior Principal Statistical Programmer, you will play a strategic and technical leadership role in clinical data programming for global assets. This includes developing datasets, generating analysis outputs, leading programming teams, and supporting integrated analysis (ISS/ISE) activities. You’ll be a key driver of innovation, process improvement, and mentorship within the statistical programming community.


📌 Key Responsibilities:

🔹 Programming Leadership & Execution:

  • Lead the trial or asset programming team as the Lead Statistical Programmer.

  • Ensure timely and high-quality deliverables across projects and programs.

  • Develop and validate:

    • SDTM and ADaM datasets

    • Analysis outputs as per the Statistical Analysis Plan (SAP)

    • Specifications and Define.xml, reviewer guides, etc.

  • Execute ad-hoc programming activities for internal and external stakeholders.

🔹 Innovation & Process Improvement:

  • Contribute to process optimization and technological advancements within statistical programming (e.g., automation, code reuse).

  • Work with advanced tools like R, Shiny, and SAS to modernize reporting and analytics.

🔹 Strategic Collaboration:

  • Provide expert guidance to global study teams across multiple therapeutic areas.

  • Support e-submissions and integrated analysis (ISS/ISE).

  • Collaborate closely with biostatistics, data management, and clinical teams.

🔹 Mentorship & Training:

  • Mentor junior programmers and promote knowledge-sharing.

  • Conduct training sessions and develop programming standards within the team.


👤 Who You Are:

🎓 Education:

  • Bachelor’s or Master’s degree in a numerate field (e.g., Mathematics, Statistics, Computer Science).

💼 Experience:

  • Minimum 9 years of experience in statistical programming in a pharma, biotech, or CRO environment.

  • Experience working in a global clinical development setting is highly desirable.

🛠 Technical Skills:

  • Expert-level proficiency in SAS and R programming.

  • Strong understanding of CDISC SDTM and ADaM standards, Define.xml, and reviewer guides.

  • Experience with e-submissions and regulatory deliverables is an asset.

💡 Competencies:

  • Strong understanding of the clinical development process.

  • Proven ability to manage and lead large datasets and programming teams.

  • Able to provide creative solutions to programming challenges.

  • Excellent communication and collaboration skills across global, cross-functional teams.


💼 What We Offer:

Merck provides more than just competitive pay—we offer a range of benefits and resources designed to help you thrive personally and professionally.

💸 Financial & Protection:

  • Long-term financial benefits for you and your family.

🧠 Health & Wellbeing:

  • Health check-ups, wellness programs, and medical insurance.

👨‍👩‍👧‍👦 Family Support:

  • Fertility and family benefits to support every stage of life.

🌴 Time Off:

  • Ample leave and time away options to recharge.

🧘 Lifestyle & Flexibility:

  • Hybrid working, gym memberships, shopping discounts, and more.


🔍 Recruitment Process:

  1. Apply: Submit your application for the role.

  2. Screen: Applications are reviewed for alignment with role requirements.

  3. Assess: Selected candidates will be invited for interviews (phone/video/in-person).

  4. Decision: Final selections made based on mutual fit.

  5. Onboarding: Tailored onboarding process to ensure a smooth start.


⚠️ Notice on Fraudulent Job Offers:

Be cautious of fake job offers claiming to represent Merck. Always apply through our official careers portal. For more information, visit the Fraudulent Job Offers notice on our website.


Apply Now:

Join Merck and become part of a global team dedicated to sparking discovery and elevating humanity through cutting-edge science and innovation.