Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Senior Manager, Biostatistics

Sun Pharma
Sun Pharma
5-10 years
preferred by company
Gurgaon, Mumbai, India
1 May 13, 2026
Job Description
Job Type: Hybrid Education: Minimum: Master’s degree (MA/MS) in Medicine, Neurology, Psychology, or related field. Preferred: MD, DO, or PhD. Skills: Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes

Job Title: Senior Manager, Biostatistics

Company: Sun Pharma
Location: Gurugram / Mumbai, India (Hybrid)
Employment Type: Full-Time
Industry: Biostatistics / Clinical Development / Pharmaceutical R&D / Global Regulatory Submissions

Job Overview

We are hiring a Senior Manager, Biostatistics to lead statistical strategy, clinical trial design, advanced data analysis, regulatory submission support, and cross-functional biostatistics leadership for registration-directed global clinical development programs.

This role is ideal for professionals with expertise in clinical biostatistics, adaptive trial design, Bayesian statistics, SAS/R programming oversight, regulatory submissions, and drug development analytics.

The successful candidate will act as a lead study biostatistician, supporting multiple clinical studies from design through submission while driving innovation in statistical methodology.


Key Responsibilities

Clinical Trial Statistical Leadership

Serve as lead study biostatistician across development programs.

Responsibilities include:

  • Supporting statistical design of clinical trials
  • Leading statistical planning across studies
  • Providing methodology guidance
  • Supporting interpretation of clinical endpoints
  • Driving evidence-based decision making

Support studies across:

  • Phase I
  • Phase II
  • Phase III
  • Phase IV

Statistical Analysis Plan Development

Author and manage key statistical documents including:

  • Statistical Analysis Plans (SAPs)
  • Table, Figure & Listing (TFL) shells
  • Statistical specifications
  • Study-related statistical documentation

Ensure alignment with:

  • Protocol objectives
  • Regulatory expectations
  • Scientific requirements

Clinical Data Analysis Oversight

Lead and oversee:

  • Statistical analyses
  • Exploratory analyses
  • Sensitivity analyses
  • Subgroup evaluations
  • Integrated analytical outputs

Provide interpretation of findings with clinical relevance.


Statistical Programming Oversight

Review and oversee:

  • AdaM specifications
  • Analysis dataset development
  • TFL generation
  • Statistical output quality

Ensure:

  • Timely delivery
  • High-quality statistical outputs
  • Submission readiness

Advanced Statistical Methodology

Apply and guide advanced statistical approaches including:

  • Bayesian statistical methods
  • Adaptive trial design
  • Power calculations
  • Sample size estimation
  • Simulation modeling
  • Design optimization

Support innovative clinical development strategies.


Regulatory Submission Support

Support global regulatory activities including:

  • NDA submissions
  • BLA submissions
  • eCTD statistical deliverables
  • Submission package statistical review
  • Regulatory response support

Provide statistical support for:

  • Health Authority requests
  • Submission clarifications
  • Regulatory interactions

Clinical Study Report Support

Contribute statistical expertise to:

  • Clinical Study Reports (CSRs)
  • Submission summaries
  • Statistical narratives
  • Data interpretation sections

Ensure scientific and regulatory quality.


Scientific Communication Support

Provide statistical support for:

  • Scientific publications
  • Conference posters
  • Medical presentations
  • Symposia materials
  • Scientific abstracts

Ensure accurate scientific interpretation of statistical findings.


Cross-Functional Collaboration

Partner with:

  • Clinical development
  • Medical teams
  • Regulatory affairs
  • Statistical programming
  • Data management
  • External vendors
  • Global study teams

Represent biostatistics in:

  • Study team meetings
  • Project discussions
  • Strategic planning reviews

Process Improvement & Standards

Contribute to:

  • Statistical SOP development
  • Process optimization
  • Methodology innovation
  • Best practice implementation
  • Team capability building
  • Technical training

Help strengthen biostatistics operational excellence.


Quality & Compliance

Ensure compliance with:

  • Regulatory requirements
  • Internal SOPs
  • Clinical development standards
  • Submission quality expectations

Maintain audit-ready statistical practices.


Required Qualifications

Education

Preferred:

  • PhD in:
    • Biostatistics
    • Statistics
    • Related quantitative disciplines

OR

Acceptable:

  • Master’s degree with significant industry experience

Experience Required

  • PhD: 5+ years relevant experience

OR

  • Master’s: 10+ years relevant experience

Preferred pharmaceutical clinical development experience.