Job Title
Associate Director – Biostatistics
Location
Gurgaon, India (Remote/Hybrid)
Department
Global Clinical Development – R&D
Company
Sun Pharmaceutical Industries Ltd
Role Overview
The Associate Director – Biostatistics is a senior scientific leadership role responsible for designing, analyzing, and interpreting clinical trial data for global regulatory submissions. The role leads statistical strategy across multiple studies and ensures scientific, regulatory, and methodological rigor in clinical development programs.
Key Responsibilities
1. Study Leadership & Statistical Strategy
Serve as lead study biostatistician across multiple clinical trials
Design statistical methodologies for clinical development programs
Ensure alignment of statistical plans with study and regulatory objectives
2. Statistical Documentation
Author Statistical Analysis Plans (SAPs)
Develop TLF shells (Tables, Listings, Figures specifications)
Review statistical documentation for accuracy and consistency
3. Clinical Data Analysis & Execution
Oversee development of ADaM datasets and TLFs
Plan and execute statistical analyses for clinical trials
Ensure high-quality deliverables for study reporting and submissions
4. Regulatory Submission Support
Provide statistical input for:
Clinical Study Reports (CSR)
NDA / BLA / eCTD submissions
Support Health Authority responses and queries
Contribute to regulatory inspection readiness
5. Cross-Functional Collaboration
Work with Clinical, Regulatory, Programming, and Data Science teams
Participate in cross-functional study and project meetings
Provide statistical consultation across development programs
6. Advanced Statistical Methodology
Contribute to innovative statistical methods and trial design
Perform simulation studies for design optimization
Support exploratory and post-hoc analyses
7. Publications & Scientific Communication
Support publications, posters, and scientific presentations
Ensure statistical integrity of scientific outputs
Present statistical findings in internal and external forums
8. Quality, Compliance & Process Improvement
Ensure compliance with SOPs, GxP, and regulatory standards
Contribute to SOP development and process improvements
Maintain audit-ready documentation and practices
Required Qualifications
Education
Ph.D. or M.S. in:
Biostatistics
Statistics
Or related quantitative discipline
Experience
Ph.D.: 10+ years industry experience
M.S.: 15+ years industry experience
Experience in pharmaceutical R&D or clinical development required
Key Technical Skills
Strong expertise in clinical trial statistics (Phase I–IV)
Proficiency in SAS and R
Experience in CDISC standards (ADaM preferred)
Experience with NDA / BLA / eCTD submissions
Knowledge of regulatory frameworks (FDA, EMA, ICH guidelines)
Experience in oncology or dermatology (preferred advantage)
Soft Skills
Strong leadership and scientific decision-making ability
Excellent communication and cross-functional collaboration skills
Ability to manage multiple complex global studies
Strong attention to scientific and regulatory detail
High accountability and results orientation
Strategic and innovative thinking
Core Function
This role ensures scientifically robust statistical leadership for clinical trials, supporting global regulatory approvals and drug development decisions.
About the Company
Sun Pharmaceutical Industries Ltd is a leading global pharmaceutical company engaged in innovative and generic drug development, with strong expertise in clinical research, biostatistics, and global regulatory submissions.
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Rangpo |India :
Remote, India | Siliguri |Illinois :
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Canada |Quebec :
Montreal |Brussels :
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Zaventem |South America :
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Brazil | Sao paulo |Attica :
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Manila |Croatia :
Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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