Manager 2 – Statistical Programming
Global Clinical Development
Location: Gurgaon (Remote / Hybrid)
Company: Sun Pharmaceutical Industries Ltd
Business Unit: Global Clinical Development
Job Grade: G11A
Role Overview
The Manager 2 – Statistical Programming is responsible for leading end-to-end clinical trial programming activities across Phase I–IV studies, ensuring high-quality deliverables for regulatory submissions and clinical study reporting.
This role sits at the intersection of:
Clinical data programming
Regulatory submission support
CDISC standards implementation
Cross-functional clinical development execution
Key Responsibilities
1. Study Programming Leadership
Lead statistical programming for one or more therapeutic areas, compounds, or indications
Ensure timely and high-quality deliverables across multiple studies
Work independently while aligning with project strategy
2. Clinical Data Standards (CDISC)
Develop and maintain:
SDTM mapping specifications
ADaM specifications
Implement CDISC standards across clinical datasets
Ensure compliance with regulatory expectations
3. SAS Programming & Dataset Development
Develop SAS programs for:
SDTM datasets
ADaM datasets
Tables, Listings, Figures (TLFs)
Ensure accuracy, reproducibility, and validation of outputs
Support clinical study reporting and submissions
4. Regulatory Submission Support
Prepare and manage submission packages including:
eCTD components
define.xml
CSR-related datasets
Support regulatory filings for:
FDA
EMA
PMDA
Handle health authority queries and data requests
5. Documentation & Compliance
Maintain programming documentation following internal standards
Contribute to:
CRF annotation
SAP review
TLF specifications and reviews
Ensure compliance with regulatory guidance and submission standards
6. Submission Package Components
Responsible for assembling and validating:
aCRF (annotated CRF)
cSDRG (clinical study data review guide)
ADRG (analysis data review guide)
ARM (analysis results metadata)
define.xml
7. Standards Development & Innovation
Develop reusable SAS macros and utilities
Maintain programming standards and libraries
Contribute to process improvement and automation
8. Cross-Functional Collaboration
Work closely with:
Biostatistics
Clinical development
Data management
Regulatory teams
Align programming outputs with statistical analysis plans
9. Mentorship & Leadership
Mentor junior programmers and new hires
Provide technical guidance and review support
Act as subject matter expert (SME) within programming team
Required Skills
Programming Expertise
Strong SAS programming in clinical data environment (mandatory)
Knowledge of:
R (preferred)
Python (plus)
Clinical & Regulatory Knowledge
Clinical trial lifecycle (Phase I–IV)
CDISC standards (SDTM, ADaM)
Regulatory submissions:
NDA
ANDA
eCTD
Technical Strengths
Data handling and transformation
Statistical output programming (TLFs)
CDISC implementation and validation
Clinical dataset integrity management
Behavioral Competencies
Strong analytical and problem-solving skills
Attention to detail and data accuracy
Ability to work independently and in global teams
Strong communication and coordination skills
Ownership and accountability
Adaptability in fast-paced environments
Mentorship mindset
Education & Experience
Bachelor’s degree in:
Statistics
Computer Science
Mathematics
Engineering
Life Sciences or related field
Experience:
4+ years in clinical trial programming
Pharmaceutical / CRO / biotech experience preferred
Role Summary (Simple View)
This role focuses on:
Writing SAS programs for clinical trials
Preparing regulatory submission datasets
Implementing CDISC standards
Supporting global drug approvals
Leading programming teams and mentoring juniors
How it differs from Biostatistics role
Statistical Programming: builds datasets, SAS code, submission packages
Biostatistics: designs studies, defines statistical methods, interprets results
They work closely but are distinct:
Programming = execution & data structure
Biostatistics = study design & statistical interpretation
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Berlin |Baden-Wurttemberg :
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Germany | GErmany |Lower Saxony :
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