Job Title
Statistical Programmer
Location
Remote / Hybrid
Company
Sun Pharmaceutical Industries Ltd
Role Overview
The Statistical Programmer is responsible for clinical trial programming, CDISC dataset creation, and regulatory submission support across multiple studies. The role ensures high-quality statistical outputs for global clinical development, regulatory filings, and clinical study reporting.
Key Responsibilities
1. Statistical Programming & Study Support
Lead programming activities across clinical studies and therapeutic areas
Support clinical study reports, ad hoc and post hoc analyses
Ensure timely and high-quality delivery of programming outputs
2. Clinical Data Standards (CDISC)
Develop SDTM and ADaM datasets following CDISC standards
Create mapping specifications and programming documentation
Ensure compliance with clinical data standards and regulatory requirements
3. SAS Programming & Reporting
Develop SAS programs for:
SDTM datasets
ADaM datasets
Tables, Listings, and Figures (TLFs)
Support validation and review of statistical outputs
Contribute to automation and macro development
4. Regulatory Submission Support
Prepare submission-ready documentation:
define.xml
aCRF
cSDRG / ADRG
ARM packages
Support FDA, EMA, PMDA, and other regulatory submissions
Ensure compliance with global submission guidelines (e.g., eCTD standards)
5. Clinical Documentation & Review
Participate in CRF annotation
Review SAP (Statistical Analysis Plan)
Review TLF specifications and outputs
Ensure consistency across clinical documentation
6. Standards Development & Governance
Contribute to SAS macro development
Support SOP development and maintenance
Participate in SME and standards governance activities
7. Mentorship & Collaboration
Mentor junior programmers and new hires
Collaborate with cross-functional teams (clinical, regulatory, biostatistics)
Coordinate with global stakeholders and external vendors
Required Qualifications
Education
Bachelor’s degree in:
Statistics
Computer Science
Mathematics
Engineering
Life Sciences
Or related discipline
Experience
2–12+ years in clinical statistical programming
Experience in pharmaceutical, biotech, CRO, or healthcare industry
Key Technical Skills
Strong SAS programming expertise
Knowledge of CDISC standards (SDTM, ADaM)
Understanding of clinical trial processes and statistical concepts
Experience with regulatory submissions (NDA, ANDA, etc.)
Familiarity with R or Python (preferred)
Knowledge of ICH guidelines and global regulatory frameworks
Soft Skills
Strong analytical and problem-solving ability
Excellent communication and teamwork skills
Ability to work independently in global teams
Attention to detail and high-quality focus
Leadership and mentoring capability
Strong ownership and accountability mindset
Core Function
This role ensures accurate, compliant, and regulatory-ready statistical programming outputs that support clinical trials, submissions, and global drug development programs.
About the Company
Sun Pharmaceutical Industries Ltd is a global pharmaceutical leader specializing in generic and specialty medicines across multiple therapeutic areas, with strong presence in clinical development and regulatory submissions worldwide.
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Remote, India | Siliguri |Illinois :
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Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
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Copenhagen | Denmark |Europe :
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Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Australia | North York | Renfrew | Uxbridge | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
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Greece |North Island :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Italy |Lombardy :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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