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Principal Biostatistician

2+ years
Not Disclosed
10 April 30, 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

Job Title: Principal Biostatistician
Job ID: 25003326
Updated On: Today

Company Overview:
Syneos Health® is a fully integrated biopharmaceutical solutions organization built to accelerate customer success. With a presence in over 110 countries and 29,000 employees, we bring clinical, medical affairs, and commercial insights together to streamline the development and delivery of therapies that change lives.

Why Join Us:

  • Career development and progression support

  • Engaged leadership and mentoring culture

  • Inclusive Total Self culture that promotes authenticity

  • Recognition programs and competitive rewards

  • Global collaboration and innovation

Key Responsibilities:

  • Serve as a statistical department resource and mentor for Biostatistics staff

  • Lead statistical activities across the project lifecycle—from protocol to Clinical Study Report (CSR)

  • Prepare or oversee Statistical Analysis Plans (SAPs) and mock-up displays for tables, listings, and figures

  • Lead or support study design, randomization, and statistical input for clinical protocols

  • Review CRFs, database designs, and programming specifications

  • Ensure high-quality deliverables through verification and quality control checks

  • Act as the Lead Biostatistician on complex or multiple projects and provide statistical representation in regulatory meetings

  • Collaborate with cross-functional teams and contribute in internal meetings with constructive input

  • Manage project timelines and proactively communicate challenges to Biostatistics management

  • Provide statistical programming support and contribute to DSMB/DMC activities as needed

  • Support business development efforts by participating in proposals, budget planning, and sponsor meetings

  • Ensure compliance with SOPs, regulatory guidelines (e.g. ICH), and maintain audit-ready documentation

  • Take initiative in contributing to team projects and continuous improvement initiatives

Qualifications:

  • Graduate degree in Biostatistics or related field

  • Proven leadership in clinical trials or equivalent combination of experience and education

  • Strong proficiency in statistical programming

  • In-depth knowledge of statistical design, regulatory guidelines, and clinical trial analysis

  • Hands-on experience across all phases of statistical support in clinical development

  • Exposure to regulatory submissions (preferred)

  • Strong written and verbal communication skills

  • Fluency in English (written and spoken)

Travel Requirement:

  • Minimal travel expected

About Syneos Health:
In the last five years, Syneos Health has partnered with 94% of all novel FDA-approved drugs and 95% of EMA-authorized products. Our global presence, scientific excellence, and unwavering drive make us a top partner for biopharmaceutical advancement.

Additional Notes:
Job responsibilities listed are not exhaustive. Syneos Health may modify responsibilities at its discretion without prior notice. The company is an equal opportunity employer and adheres to applicable laws and directives, including the ADA and EU Equality Directive.