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Associate Director - Statistical Programmer

10 years years
Not Disclosed
10 Aug. 30, 2025
Job Description
Job Type: Full Time Education: BSc or 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

πŸ“Œ Job Title:

Associate Director – Statistical Programmer

πŸ†” Job ID:

291278

πŸ“ Location:

Hyderabad, Andhra Pradesh, India

πŸ•’ Job Type:

Full-time


🌍 About Merck:

At Merck, we are passionate about innovation and impact. Across Healthcare, Life Science, and Electronics, our teams dream big and work hard to develop solutions that improve lives. We are committed to inclusion, diversity, and sustainability, and seek out curious minds who are driven to imagine the unimaginable.


🎯 Role Overview:

As an Associate Director – Statistical Programmer, you will take a strategic leadership role in managing programming activities for global clinical development assets. You will guide teams, ensure compliance with regulatory standards, and contribute to data-driven decision-making using advanced tools like SAS, R, and Shiny.

This position plays a critical role in shaping statistical programming strategies across various therapeutic areas, driving high-quality data submissions, and mentoring programming staff.


πŸ›  Key Responsibilities:

πŸ”Ή Programming Leadership:

  • Lead one or more asset programming teams as the Lead Statistical Programmer.

  • Ensure timely and quality delivery of programming tasks for assigned clinical studies or programs.

πŸ”Ή Programming Deliverables:

  • Develop and validate SDTM and ADaM datasets in compliance with CDISC standards.

  • Create and validate outputs (e.g., tables, listings, figures) per the Statistical Analysis Plan (SAP).

  • Support integrated summaries (ISS/ISE) and associated datasets.

πŸ”Ή Regulatory Submissions:

  • Create submission-ready data packages, including:

    • define.xml

    • cSDRG (Clinical Study Data Reviewer’s Guide)

    • ADRG (Analysis Data Reviewer’s Guide)

  • Support e-submissions to global regulatory authorities.

πŸ”Ή Strategic & Technical Excellence:

  • Solve complex programming challenges and evaluate multiple technical approaches.

  • Execute ad-hoc programming requests from internal and external stakeholders.

  • Contribute to innovation and process improvement initiatives in the Statistical Programming function.

πŸ”Ή Mentorship & Collaboration:

  • Provide guidance and training to junior staff and cross-functional teams.

  • Foster team development and knowledge sharing across global programming teams.


πŸ‘€ Candidate Profile:

πŸŽ“ Education:

  • BSc or MSc in a numerate discipline (e.g., Mathematics, Statistics, Computer Science).

πŸ’Ό Experience:

  • Minimum 10 years of experience in Statistical Programming within clinical development in pharmaceutical, biotech, or CRO settings.

  • Experience in international environments is advantageous.

🧰 Technical Skills:

  • Advanced proficiency in SAS and R (experience with Shiny is a plus).

  • Expert knowledge of CDISC standards (SDTM, ADaM) and associated documentation (define.xml, reviewer’s guides).

  • Familiarity with clinical trial processes, regulatory submissions, and data lifecycle management.

🧠 Core Competencies:

  • Strong analytical, problem-solving, and organizational skills.

  • Demonstrated ability to lead programming teams across multiple studies or assets.

  • Capable of evaluating programming options to ensure optimal delivery quality and timelines.

  • Excellent communication and stakeholder collaboration skills.


πŸ’Ό What We Offer:

Merck provides a wide range of benefits to support your health, career, and personal development:

πŸ’° Financial & Protection:

  • Competitive compensation and financial planning support.

🧠 Health & Wellbeing:

  • Health checkups, medical insurance, and mental wellness support.

πŸ‘¨‍πŸ‘©‍πŸ‘§‍πŸ‘¦ Family:

  • Fertility benefits and flexible support for various family needs.

🌴 Time Away:

  • Paid leaves for personal time off, recharge, and life events.

🧘 Lifestyle:

  • Flexible working hours, gym memberships, vehicle benefits, and shopping discounts.


πŸ” Recruitment Process:

  1. Application Submission:
    Apply online for your preferred position.

  2. Screening:
    Applications are reviewed for best-fit qualifications.

  3. Assessment:
    Shortlisted candidates undergo interviews (phone/video/in-person).

  4. Mutual Agreement:
    If selected, you receive an offer and onboarding begins.


⚠️ Fraudulent Job Offers – Notice:

Please be aware of fraudulent job offers claiming to represent Merck. Verify authenticity via Merck’s official career portal. More information on avoiding scams is available on the company website.


βœ… Apply Now:

Join Merck and work your magic to advance science, data integrity, and healthcare outcomes. Be part of a global, inclusive team that’s improving lives through technology and innovation.