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Principal Biostatistician

6+ years
Not Disclosed
10 July 9, 2025
Job Description
Job Type: Full Time Education: Master’s or Ph.D 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 – Remote, India

Job Summary:
Syneos Health is seeking an experienced Principal Biostatistician to lead statistical activities for clinical trial programs. In this remote India-based role, you will collaborate with cross-functional teams to deliver high-quality statistical analyses supporting regulatory submissions and drug development. You’ll work on cutting-edge projects across therapeutic areas, bringing statistical expertise to one of the world’s most recognized clinical research organizations.


Key Responsibilities:

  • Serve as the lead biostatistician on clinical trials and ensure timely delivery of statistical outputs

  • Provide statistical consultation to project teams, sponsors, and regulatory authorities

  • Contribute to statistical sections of protocols, study reports, and submission documents

  • Review statistical analysis plans and ensure alignment with study objectives

  • Guide programming teams on statistical deliverables and validation

  • Participate in audits and ensure compliance with ICH-GCP and regulatory guidelines

  • Mentor and guide junior statisticians within the team


Required Skills & Qualifications:

  • Master’s or Ph.D. in Biostatistics, Statistics, or a related discipline

  • Minimum 6+ years of experience in pharmaceutical/CRO industry in clinical trials

  • Strong proficiency in SAS programming and clinical data analysis

  • In-depth knowledge of ICH-GCP, CDISC standards, and FDA/EMA statistical requirements

  • Experience with regulatory submissions (NDA, BLA, etc.)

  • Excellent communication and collaboration skills


Perks & Benefits:

  • Fully remote working model across India

  • Career advancement and leadership development opportunities

  • Access to global biostatistics and therapeutic training

  • Work with novel FDA/EMA drug programs

  • Inclusive and supportive company culture


Company Description:

Syneos Health is a global, fully integrated biopharmaceutical solutions organization supporting the development and commercialization of novel therapeutics. With expertise across 110 countries and involvement in 94% of FDA-approved novel drugs, Syneos Health is driving innovation in life sciences and clinical research.


Work Mode: Remote – India


Call-to-Action:
Advance your biostatistics career with Syneos Health. Apply now to become a key contributor to clinical excellence and global drug development.