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Manager Biostatistician (Manager, Biostats)

Sun Pharma
Sun Pharma
2+ years
preferred by company
Gurgaon, Remote
1 May 13, 2026
Job Description
Job Type: Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: 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, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines

Job Title: Manager Biostatistician (Manager, Biostats)

Company: Sun Pharma
Location: Gurgaon / Remote / Hybrid
Business Unit: Global Clinical Development
Employment Type: Full-Time
Industry: Biostatistics / Clinical Development / Pharmaceutical R&D / Drug Development

Job Overview

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

This role is ideal for professionals with expertise in clinical biostatistics, statistical methodology, regulatory submissions, statistical programming collaboration, drug development, and clinical data interpretation.

The successful candidate will support registration-directed clinical trials across the development lifecycle and contribute to regulatory submissions, scientific publications, and statistical innovation.


Key Responsibilities

Clinical Trial Statistical Design

Lead statistical strategy for clinical development programs by:

  • Designing statistically sound study methodologies
  • Supporting scientific protocol development
  • Defining analysis approaches aligned with project strategy
  • Ensuring regulatory acceptability of statistical designs

Support studies across:

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

Statistical Analysis Plan (SAP) Development

  • Develop and review Statistical Analysis Plans (SAPs).
  • Ensure methodology aligns with:
    • Protocol objectives
    • Regulatory expectations
    • Clinical strategy
    • Scientific rigor

Provide clear statistical implementation guidance.


Database & Data Standards Collaboration

Collaborate with:

  • Data sciences teams
  • Statistical programming
  • Clinical development stakeholders
  • Cross-functional project teams

Responsibilities include:

  • Data collection strategy
  • Database implementation review
  • Data standards development
  • Data monitoring support
  • Data quality governance

Ensure analysis-ready, accurate clinical data.


Statistical Analysis Leadership

  • Lead execution and oversight of clinical statistical analyses.
  • Ensure all planned analyses are scientifically and methodologically appropriate.
  • Recommend advanced or novel statistical approaches when needed.

Responsibilities include:

  • Methodology selection
  • Analysis oversight
  • Programming guidance
  • Statistical interpretation

Advanced Statistical Methodology

Apply expertise in:

  • Clinical trial statistical methodologies
  • Novel analytical approaches
  • Efficiency optimization
  • Sensitivity improvement techniques

Drive innovation in clinical statistical analysis.


Reporting & Scientific Communication

Support creation and review of:

  • Clinical study reports
  • Scientific publications
  • Statistical summaries
  • Oral presentations
  • Management review presentations

Ensure statistical conclusions are:

  • Scientifically accurate
  • Clearly presented
  • Clinically meaningful

Publication Support

Provide in-depth statistical review for:

  • Scientific manuscripts
  • Publications
  • Research reports
  • Clinical communications

Ensure statistical integrity of published evidence.


Cross-Functional Project Leadership

Partner with:

  • Clinical development
  • Regulatory affairs
  • Data sciences
  • Statistical programming
  • Project teams
  • External vendors

Act as biostatistics representative on project teams.

Drive:

  • Strategic decision making
  • Timeline alignment
  • Statistical communication
  • Risk resolution

Regulatory Support

Support global regulatory activities including:

  • Regulatory submission document review
  • Statistical sections of submissions
  • Agency interaction support
  • Statistical regulatory compliance

Preferred exposure:

  • NDA submissions
  • BLA submissions
  • eCTD submission environments

Compliance & Quality

Ensure compliance with:

  • GxP standards
  • Regulatory requirements
  • SOPs
  • Statistical governance standards
  • Corporate quality expectations

Maintain audit-ready statistical practices.


Team Leadership & Mentoring

  • Train and mentor statistical team members.
  • Support methodological learning.
  • Participate in internal seminars and scientific development activities.

For people managers:

  • Manage direct reports
  • Support hiring
  • Guide team development
  • Build capability

Software & Tools

Use and guide teams in:

  • SAS
  • R
  • Statistical validation environments
  • Analysis workflows

Required Qualifications

Education

PhD or MS in:

  • Biostatistics
  • Statistics
  • Related quantitative disciplines

Experience Required

  • PhD: 2+ years industry experience

OR

  • MS: 5+ years pharmaceutical R&D experience

Preferred:

  • Pharmaceutical clinical development background