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Title: Manager, Biostatistics

Sun Pharma
2+ years
₹18 – ₹30 LPA
Gurgaon, Gurugram, India
15 Aug. 6, 2026
Job Description
Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Analytical Characterization, Dissolution Testing, Experimental Design, GMP/cGMP Compliance, HPLC, HPLC Analysis, Pre-formulation Studies, Regulatory Filing Support, Root Cause Analysis (RCA), Technology Transfer, UPLC

Manager – Biostatistics

Company: Sun Pharmaceutical Industries Limited
Business Unit: Global Clinical Development
Job Title: Manager, Biostatistics
Job Grade: Manager
Location: Gurgaon – R&D / Remote / Hybrid
Job Type: Full-time


Experience Required

  • Ph.D. in Biostatistics/Statistics: Minimum 2+ years of industry experience in pharmaceutical R&D or equivalent.

  • M.S./M.Sc. in Biostatistics/Statistics: Minimum 5+ years of industry experience.

Preferred experience:

  • Clinical trial statistical analysis.

  • Global regulatory submissions.

  • Pharmaceutical R&D environment.

  • Phase I–IV clinical development.

  • Oncology or dermatology clinical trials (preferred).


Educational Qualification

Required:

  • Ph.D. in Biostatistics or Statistics

OR

  • M.S./Master’s Degree in Biostatistics or Statistics


Department

Global Clinical Development – Biostatistics


Job Summary

Sun Pharma is hiring a Manager – Biostatistics to support the design, execution, analysis, and interpretation of registration-directed clinical trials and global regulatory submissions.

The role involves providing statistical leadership across clinical development programs, designing statistical methodologies, developing analysis plans, supporting regulatory submissions, ensuring data quality, and collaborating with clinical, regulatory, data science, and programming teams.

The selected candidate will act as a statistical subject matter expert and contribute to improving biostatistical standards, procedures, and analytical strategies within Global Clinical Development.


Key Responsibilities

Clinical Trial Statistical Design

  • Lead statistical design and analysis strategies for clinical trial protocols.

  • Ensure statistical approaches are:

    • Scientifically valid

    • Regulatory compliant

    • Aligned with development objectives

  • Develop and review Statistical Analysis Plans (SAPs).

  • Support creation of data collection and analysis standards.

  • Ensure statistical methodology supports clinical objectives.


Database & Data Management Support

  • Collaborate with:

    • Data Sciences teams

    • Statistical Programming teams

    • Clinical teams

    • Other stakeholders

  • Ensure clinical databases support project requirements.

  • Contribute to:

    • Data monitoring plans

    • Data standards development

    • Database implementation strategies

  • Ensure accuracy and consistency of clinical data released for statistical analysis.


Statistical Analysis Activities

  • Apply advanced statistical concepts and methodologies.

  • Perform interpretation of clinical trial data.

  • Recommend innovative statistical approaches.

  • Improve efficiency and sensitivity of study analyses.

  • Provide statistical specifications for programming implementation.

  • Ensure analyses follow:

    • Protocol requirements

    • SAP methodology

    • Regulatory expectations


Clinical Reports & Publications

  • Review statistical sections of:

    • Clinical study reports

    • Scientific publications

    • Regulatory documents

  • Ensure statistical conclusions are scientifically accurate.

  • Prepare statistical reports and presentations.

  • Communicate findings to:

    • Project teams

    • Management

    • Regulatory stakeholders


Cross-Functional Project Leadership

Collaborate with:

  • Clinical Development Teams

  • Regulatory Affairs

  • Data Management

  • Statistical Programming

  • Medical Affairs

Responsibilities include:

  • Providing statistical input into drug development strategies.

  • Representing Biostatistics in project meetings.

  • Ensuring alignment between project teams and statistical functions.

  • Supporting decision-making through statistical insights.


Training & Team Management

  • Mentor and train statisticians on:

    • Statistical methodologies

    • Clinical trial operations

    • Best practices

  • Support professional development activities.

  • Participate in:

    • Statistical seminars

    • Scientific presentations

    • Training programs

  • People managers will manage 2 or more direct reports.


Regulatory Activities

  • Support global regulatory submissions.

  • Review regulatory submission documents.

  • Participate in regulatory agency discussions.

  • Ensure compliance with:

    • GxP requirements

    • SOPs

    • Regulatory guidelines

  • Validate external statistical software according to regulatory standards.


Compliance Responsibilities

  • Maintain knowledge of:

    • Statistical SOPs

    • Regulatory requirements

    • Department procedures

  • Ensure compliance with:

    • Corporate policies

    • Clinical development standards

    • Good operating practices

  • Complete assigned training requirements on time.


Required Skills

  • Clinical Trial Biostatistics

  • Statistical Analysis

  • Clinical Data Interpretation

  • Statistical Analysis Plans (SAP)

  • SAS Programming

  • R Programming

  • Phase I–IV Drug Development

  • Regulatory Submission Support

  • Clinical Study Reports

  • Data Standards

  • Statistical Methodology

  • Pharmaceutical R&D Knowledge

  • Project Management

  • Team Leadership

  • Scientific Communication


Preferred Skills

  • NDA/BLA submission experience.

  • eCTD regulatory submission knowledge.

  • Oncology clinical development experience.

  • Dermatology clinical development experience.

  • Experience working with global clinical programs.

  • Knowledge of innovative statistical methodologies.


Roles and Responsibilities

  • Provide statistical leadership for clinical development programs.

  • Design and implement statistical strategies.

  • Ensure scientific quality of analyses and reports.

  • Support regulatory approval activities.

  • Mentor statistical team members.

  • Manage multiple projects and priorities.

  • Identify risks and develop solutions.

  • Deliver high-quality statistical outputs within timelines.


Work Environment

  • Full-time Manager-level role.

  • Remote/Hybrid work model.

  • Collaboration with global clinical development teams.

  • Cross-functional interaction with clinical, regulatory, and data science groups.


Estimated Salary Package

The official job posting does not disclose compensation details. Based on market trends for Biostatistics Manager roles in Indian pharmaceutical R&D:

Experience

Estimated Annual CTC

PhD + 2–5 years

₹18 – ₹30 LPA

M.S./M.Sc. + 5–8 years

₹25 – ₹40 LPA

Senior Biostatistics Manager

₹35 – ₹50+ LPA

Expected Average CTC: ₹25–40 LPA, depending on clinical trial experience, SAS/R expertise, regulatory submission exposure, leadership responsibilities, and Sun Pharma compensation structure.


Who Should Apply

Ideal candidates:

  • Ph.D. or Master’s degree in Biostatistics/Statistics.

  • Experience in pharmaceutical clinical development.

  • Strong knowledge of statistical methods and clinical trial analysis.

  • SAS and R programming experience.

  • Understanding of Phase I–IV drug development.

  • Experience supporting regulatory submissions.

  • Strong leadership and communication skills.


Location

  • Gurgaon – R&D, India

  • Remote / Hybrid Option Available


Employment Type

  • Full-time

  • Manager Level Position


Key Highlights

  • Leadership role within Sun Pharma’s Global Clinical Development team.

  • Opportunity to support global registration-directed clinical trials.

  • Exposure to regulatory submissions and advanced statistical methodologies.

  • Collaboration with multidisciplinary pharmaceutical R&D teams.

  • Opportunity to mentor statisticians and influence clinical development strategies.

  • Hybrid work flexibility.