Associate Director, Biostatistics
Location: Hyderabad, Telangana, India
Company: Bristol Myers Squibb
Requisition ID: R1601655
Employment Type: Full-time
Role Summary
The Associate Director, Biostatistics is a senior scientific leadership role responsible for providing statistical expertise across clinical development programs. The role contributes to clinical trial design, regulatory submissions, and overall drug development strategy while ensuring compliance with global regulatory and statistical standards.
The position includes both technical leadership and people management responsibilities, depending on assignment.
Key Responsibilities
1. Clinical Trial Design and Strategy
Collaborate in designing innovative and efficient clinical trials
Define study populations and endpoints aligned with study objectives
Contribute to clinical development strategy
Review and defend clinical protocols and statistical analysis plans
2. Statistical Analysis and Study Documentation
Independently author or review:
Study protocols
Statistical Analysis Plans (SAPs)
Clinical Study Reports (CSRs)
Scientific publications and related documents
Present statistical analyses in a clear, accurate, and transparent manner
3. Regulatory and Scientific Support
Provide statistical input for regulatory authority submissions
Support responses to health authority queries
Contribute to scientific publications, presentations, and public disclosures
4. Study and Portfolio Management
Manage multiple clinical studies within a therapeutic area
Ensure consistency in statistical methodology across studies
Maintain compliance with internal SOPs and global regulatory standards
5. Cross-functional Collaboration
Act as a scientific and strategic partner in cross-functional clinical teams
Collaborate with clinicians, regulatory teams, and data management teams
Support data-driven decision-making in clinical development programs
6. Leadership and Mentoring (if applicable)
Mentor and develop junior statisticians and team members
Conduct performance reviews and provide feedback
Support team capability development and training
Promote a collaborative and inclusive work environment
7. Capability Development and Innovation
Expand expertise beyond statistics into clinical, regulatory, and commercial domains
Contribute to methodological innovation in clinical trial design and analysis
Participate in internal and external statistical communities of practice
Qualifications and Experience
Education
PhD in Statistics or Biostatistics with 6+ years of experience
OR
Master’s degree in Statistics or Biostatistics with 8+ years of experience
Technical Skills
Proficiency in SAS, R, or Python
Experience in advanced statistical modeling and clinical trial analysis
Strong capability in data manipulation, simulation, and visualization
Domain Knowledge
Strong understanding of clinical trial methodology
Experience in drug development lifecycle
Knowledge of regulatory requirements and interactions with health authorities
Soft Skills
Strong communication and presentation skills
Excellent organizational and project management abilities
Ability to manage multiple priorities in a complex environment
Strong collaboration and leadership skills
Preferred Experience
Experience with regulatory submissions and interactions
Prior experience in people management is preferred for leadership roles
Role Nature
Senior-level scientific leadership position
Combines technical statistical expertise with strategic clinical development responsibilities
Works in a cross-functional, matrix environment
Ensures compliance with global regulatory and quality standards
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Remote, India | Siliguri |Illinois :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Kyiv |Lima Region :
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