Associate Director – Statistical Programmer
291278
Hyderabad, Andhra Pradesh, India
Full-time
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.
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.
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.
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.
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.
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.
Provide guidance and training to junior staff and cross-functional teams.
Foster team development and knowledge sharing across global programming teams.
BSc or MSc in a numerate discipline (e.g., Mathematics, Statistics, Computer Science).
Minimum 10 years of experience in Statistical Programming within clinical development in pharmaceutical, biotech, or CRO settings.
Experience in international environments is advantageous.
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.
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.
Merck provides a wide range of benefits to support your health, career, and personal development:
Competitive compensation and financial planning support.
Health checkups, medical insurance, and mental wellness support.
Fertility benefits and flexible support for various family needs.
Paid leaves for personal time off, recharge, and life events.
Flexible working hours, gym memberships, vehicle benefits, and shopping discounts.
Application Submission:
Apply online for your preferred position.
Screening:
Applications are reviewed for best-fit qualifications.
Assessment:
Shortlisted candidates undergo interviews (phone/video/in-person).
Mutual Agreement:
If selected, you receive an offer and onboarding begins.
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.
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.
Gujarat :
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Ranchi |Sikkim :
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
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Tallinn |Hà Nội :
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Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
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Prague |Chile :
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