Scientist – Clinical Trials (Biostatistician)
Division: Discovery Services
Department: Biometrics (Biostatistics & Programming)
Location: Bengaluru, India (Semicon Park)
Employment Type: Full-time
Experience Required: 2–3 years
Date Posted: January 22, 2026
About Syngene
Syngene is an innovation-led Contract Research, Development, and Manufacturing Organization (CRDMO) providing integrated scientific services from early discovery through commercial supply. With a strong global presence, Syngene partners with leading pharmaceutical, biotechnology, and life sciences companies to deliver high-quality, compliant, and data-driven research solutions.
At Syngene, safety, quality, and data integrity are foundational to our culture. We maintain rigorous standards across Environment, Health, Safety (EHS), and regulatory compliance, with shared responsibility across all roles.
Role Overview
Syngene is seeking a Scientist – Clinical Trials (Biostatistician) to join its Biometrics Department. This role is responsible for performing biostatistical activities across Phase I–IV clinical studies, supporting clinical development programs through robust statistical planning, analysis, and reporting.
The position is ideal for professionals with hands-on experience in clinical trial biostatistics, strong SAS programming expertise, and exposure to pharmacokinetics and regulatory-driven clinical research.
Key Responsibilities
Biostatistical Support for Clinical Trials
Review clinical trial protocols and provide statistical inputs
Prepare and review Statistical Analysis Plans (SAP) and Randomization Analysis Plans (RAP)
Perform sample size calculations and statistical consultations
Conduct statistical analyses in accordance with protocol and SAP
Prepare and review randomization lists
Statistical Reporting & Deliverables
Generate and review Tables, Listings, and Graphs (TLGs)
Prepare and review statistical reports for clinical studies
Support blinding and unblinding documentation activities
Address statistical queries from internal teams and external clients
Process & Compliance
Develop, review, and maintain biostatistics-related SOPs
Ensure compliance with regulatory guidelines, internal quality standards, and data integrity requirements
Support audits, inspections, and client interactions as required
Perform additional responsibilities aligned with organizational needs
Safety, Quality & Compliance Expectations
Adhere to Syngene’s EHS, quality, and data integrity standards at all times
Complete all mandatory safety and compliance training within defined timelines
Contribute to a culture of operational discipline, scientific excellence, and continuous improvement
Required Qualifications
Education:
M.Sc. in Statistics or equivalent degree in Statistics
Ph.D. in Statistics is an added advantage
Experience Required:
2–3 years of hands-on experience in biostatistics for clinical trials
Exposure to Phase I–IV clinical studies, including pharmacokinetics
Key Skills & Competencies
Strong expertise in SAS programming
Solid understanding of clinical trial design and biostatistical methodologies
Experience supporting pharmacokinetic and clinical development studies
Strong analytical, problem-solving, and documentation skills
Effective communication skills with the ability to interface with clients and cross-functional teams
Syngene Core Values
All employees are expected to consistently demonstrate alignment with Syngene’s core values:
Excellence
Integrity
Professionalism
Equal Opportunity Employer
Syngene is an equal opportunity employer committed to fostering a diverse and inclusive workplace. Employment decisions are made without regard to age, race, gender, disability, religion, sexual orientation, marital status, or any other legally protected characteristic. Reasonable accommodations are provided to qualified individuals in accordance with applicable laws.
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