Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Principal Biostatistician

Syneos Health
Syneos Health
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.