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Principal Biostatistician

7+ years
Not Disclosed
10 June 25, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 

Principal Biostatistician – Pune, Maharashtra

Job Summary:

Syneos Health is seeking a Principal Biostatistician in Pune, India, to lead and manage statistical strategies for global clinical trials. This role is pivotal in delivering statistical support from study design through regulatory submissions. Ideal for experienced biostatistics professionals with strong expertise in SAS, CDISC, and regulatory standards, this position offers the opportunity to work in a dynamic, global, and collaborative pharmaceutical environment.


Key Responsibilities:

  • Lead statistical design and analysis planning for clinical studies across multiple phases

  • Serve as primary statistical contact for internal teams and external sponsors

  • Develop and review statistical analysis plans (SAPs), ADaM specifications, and TLF shells

  • Perform statistical analyses using SAS and validate results for regulatory compliance

  • Ensure deliverables align with CDISC standards and global regulatory guidelines

  • Participate in regulatory submissions, including responses to health authority queries

  • Provide mentorship to junior biostatisticians and review their deliverables for quality

  • Support study setup, interim reviews, database locks, and final analysis processes

  • Contribute to the development of biostatistical methodologies and SOPs

  • Work cross-functionally with data management, programming, and medical writing teams


Required Skills & Qualifications:

  • Ph.D. or Master’s degree in Biostatistics, Statistics, or related field

  • Minimum 7+ years of experience in clinical biostatistics in the pharmaceutical/CRO industry

  • Advanced knowledge of SAS programming, especially in statistical procedures

  • Proficient in CDISC standards including SDTM and ADaM

  • Familiarity with regulatory guidelines (ICH E9, E3, GCP, FDA/EMA standards)

  • Strong analytical, communication, and leadership skills

  • Experience supporting global clinical trials and regulatory submissions


Perks & Benefits:

  • Competitive salary and incentive-based rewards

  • Access to global career development and therapeutic training

  • Work with a diverse team across 110+ countries

  • Be part of a company contributing to 94% of all FDA-approved drugs

  • A culture of inclusivity and recognition under the Total Self philosophy

  • Opportunity to lead high-impact projects in a clinical research-focused environment


Company Description:

Syneos Health is a global leader in integrated biopharmaceutical solutions. The company partners with pharmaceutical and biotech organizations to deliver successful clinical trials and commercialization outcomes. With over 29,000 employees in 110 countries, Syneos supports clinical research across multiple therapeutic areas, making a meaningful difference in healthcare.


Work Mode:

On-site – Pune, Maharashtra, India


Call to Action:

Ready to take your biostatistics career to the next level? Join Syneos Health as a Principal Biostatistician and drive innovation in clinical research.