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Sr Biostatistician

0-2 years
Not Disclosed
10 Sept. 22, 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

Job Title:

Sr Biostatistician

Location: Pune, India (Hybrid)
Job ID: 25101343
Updated: September 17, 2025


Company Overview – Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success by delivering clinical, medical affairs, and commercial solutions.

Key Highlights:

  • Operates in 110 countries with 29,000 employees.

  • Partnered with 94% of Novel FDA Approved Drugs, 95% of EMA Authorized Products, 200+ studies, 73,000 sites, and 675,000+ trial patients over the past 5 years.

  • Promotes career development, technical training, peer recognition, and a Total Self culture.

Learn more: Syneos Health


Role Summary

The Sr Biostatistician provides statistical leadership and oversight for clinical research studies. This includes designing, analyzing, and interpreting clinical trial data, supporting study teams, and ensuring compliance with regulatory guidelines. The role is suited for individuals with significant experience in biostatistics, clinical trials, and regulatory requirements.


Key Responsibilities

Note: Detailed responsibilities were not explicitly listed in the source, but typically include:

  • Statistical Leadership:

    • Lead the statistical design, analysis, and interpretation of clinical studies.

    • Develop statistical analysis plans (SAPs) and review programming specifications.

  • Project Oversight:

    • Collaborate with study teams, including Clinical Operations, Medical Writing, and Programming.

    • Support study design, randomization, sample size calculations, and data validation.

  • Compliance & Quality:

    • Ensure adherence to ICH-GCP guidelines, regulatory requirements, and company SOPs.

    • Maintain up-to-date project documentation and inspection readiness.

  • Team Support & Mentorship:

    • Mentor junior biostatisticians and statistical programmers.

    • Provide guidance on complex statistical issues and troubleshooting.


Qualifications & Skills

  • Education: Graduate degree in Biostatistics or related discipline.

  • Experience: Significant experience in clinical trials, biostatistical analysis, and regulatory guidance.

  • Skills:

    • Knowledge of statistical design, analysis methodologies, and programming techniques.

    • Excellent communication, presentation, and interpersonal skills.

    • Proficiency in relevant software for statistical programming and data analysis.


Additional Information

  • Tasks and responsibilities are not exhaustive; additional duties may be assigned.

  • Equivalent experience may be considered in lieu of formal qualifications.

  • Nothing in this description constitutes an employment contract.

  • Syneos Health complies with ADA and applicable local regulations.


How to Apply

  • Apply via the Syneos Health website.

  • Not ready to apply? Join the Talent Network to stay connected for future opportunities.