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Biostatistician

Syngene
Syngene
0-2 years
Not Disclosed
10 Dec. 29, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Junior Manager – Biostatistics
Location: Semicon Park, Bangalore, India
Division: Discovery Services
Department: Biostatistics & SAS Programming
Employment Type: Full-Time

Company Overview:
Syngene International is an innovation-led contract research, development, and manufacturing organization (CRDMO) providing integrated scientific services from early discovery through commercial supply. With safety, integrity, and excellence at the core, Syngene fosters a culture that emphasizes scientific rigor, operational discipline, and compliance with global standards.

Role Overview:
The Junior Manager – Biostatistics will perform advanced biostatistical activities in support of clinical studies (Phase I-IV), ensuring statistical integrity, analysis quality, and adherence to protocols and regulatory guidelines. This role involves mentoring junior statisticians, supporting clinical operations, and providing expert statistical consultation.

Key Responsibilities:

  • Review study protocols and contribute to Statistical Analysis Plans (SAP) and Randomization Allocation Plans (RAP).

  • Conduct sample size calculations and provide statistical consultation.

  • Prepare and review randomization lists, tables, listings, graphs, and statistical reports.

  • Perform statistical analysis in alignment with SAP and protocol requirements.

  • Review SDTM and ADaM datasets for accuracy and compliance.

  • Support blinding and unblinding documentation processes.

  • Develop, review, and maintain Standard Operating Procedures (SOPs) in biostatistics.

  • Mentor and guide associate biostatisticians and junior programmers.

  • Handle statistical queries from clients and provide technical guidance to cross-functional teams.

  • Contribute to team objectives, performance appraisals, and continuous improvement initiatives.

Essential Qualifications & Experience:

  • M.Sc. or Ph.D. in Statistics or equivalent.

  • Expertise in SAS programming and statistical software.

  • Hands-on experience in clinical trials, including Phase I-IV studies and pharmacokinetics studies.

  • Strong analytical, problem-solving, and documentation skills.

  • Excellent communication skills for client interactions and cross-functional collaboration.

Core Values & Leadership Expectations:

  • Uphold Excellence, Integrity, and Professionalism in all work.

  • Promote a culture of Environment, Health, Safety, and Sustainability (EHSS).

  • Provide leadership in people management, career planning, and talent retention (for leadership hires).

Equal Opportunity Employer:
Syngene provides equal employment opportunities to all qualified candidates and ensures reasonable accommodations for individuals with disabilities.

Learn More: Syngene Careers – Discovery Services