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Sr Biostatistician

0-2 years
Not Disclosed
10 Sept. 24, 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

Sr Biostatistician – Syneos Health

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


About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating clinical development and improving patient outcomes.

  • Employees: 29,000 across 110 countries

  • Experience: 94% of Novel FDA-approved drugs, 95% EMA-authorized products, 200+ studies, 73,000 sites, 675,000+ trial patients

  • Culture: Total Self culture fostering diversity, authenticity, career growth, and inclusion


Job Overview

The Sr Biostatistician is responsible for leading statistical analysis activities and providing strategic input for clinical research projects. The role involves advanced statistical design, analysis, interpretation, and reporting to support clinical trials and regulatory submissions.


Key Responsibilities

(Note: Specific duties were not detailed in the original posting; typical responsibilities for this role include)

  • Lead the development of Statistical Analysis Plans (SAPs) and study-specific analysis strategies.

  • Oversee statistical programming, data validation, and quality control of clinical trial data.

  • Provide statistical guidance to study teams, including study design, sample size estimation, and randomization plans.

  • Ensure adherence to regulatory guidelines (ICH, FDA) and company SOPs.

  • Serve as the primary statistical contact for sponsors and cross-functional project teams.

  • Mentor junior biostatisticians and support their professional development.

  • Maintain project documentation and ensure inspection readiness.

  • Support interpretation of results for clinical study reports, publications, and regulatory submissions.


Qualifications & Requirements

  • Graduate degree in Biostatistics, Statistics, or related field

  • Extensive experience in clinical trials and statistical analysis

  • Strong knowledge of clinical trial methodology, study design, and relevant regulatory guidelines

  • Proficiency in statistical software (e.g., SAS, R)

  • Excellent communication, presentation, and interpersonal skills

  • Ability to work independently and lead multi-functional project teams


Additional Information

  • Tasks and responsibilities may vary at company discretion

  • Equivalent experience, skills, or education may be considered

  • Compliance with ADA and diversity/inclusion policies

  • Expressing interest adds you to Syneos Health’s talent pipeline for upcoming opportunities