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Principal Biostatistician

2+ years
Not Disclosed
10 March 24, 2025
Job Description
Job Type: Full Time Education: M.Sc./PhD 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
Updated: March 19, 2025
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25002031

Description

Principal Biostatistician
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything we do. We continuously seek ways to simplify and streamline our work, making Syneos Health easier to work with and for.

Discover what our 29,000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

  • Career development, progression, and technical/therapeutic area training.

  • Supportive and engaged line management with peer recognition and total rewards programs.

  • Our Total Self culture allows authenticity and inclusivity, where diversity of thoughts, backgrounds, and perspectives fosters belonging.

Job Responsibilities:

  • Mentor biostatisticians, oversee or develop training materials, and conduct training sessions.

  • Direct the activities of biostatistics personnel to ensure timely completion of high-quality work.

  • Independently review project work produced by other biostatisticians.

  • Provide support across all statistical tasks during the project lifecycle.

  • Prepare and oversee Statistical Analysis Plans (SAPs) and collaborate with sponsors if required.

  • Act as Lead Biostatistician for statistical aspects of protocols, generate randomization schedules, and contribute to clinical study reports.

  • Create and review programming specifications for datasets, tables, listings, and figures.

  • Review SAS annotated case report forms (CRFs), database designs, and other study documentation to ensure quality data.

  • Implement company objectives and create solutions to address business and operational challenges.

  • Participate in verification and quality control of project deliverables to ensure consistency with SAP and specifications.

  • Lead complex or multiple projects, including submissions and integrated analyses.

  • Attend regulatory agency meetings or respond to questions to support clinical trial results.

  • Manage scheduling, prioritize timelines, and proactively communicate with biostatistics management.

  • Identify out-of-scope tasks and escalate to management.

  • Provide statistical programming support when needed.

  • Participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities.

  • Maintain well-organized project documentation and ensure inspection readiness.

  • Support business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.

  • Perform other work-related duties as assigned.

  • Minimal travel may be required.

Qualifications:

  • Postgraduate degree in biostatistics or related discipline (MSc or PhD).

  • Extensive clinical trial experience or equivalent education and experience.

  • Proficiency in programming with experience in early and late phases of clinical trials.

  • Deep knowledge of statistical design, analysis, regulatory guidelines, and programming techniques.

  • Experience with regulatory submissions preferred.

  • Strong written and verbal communication skills.

  • Proficiency in English (reading, writing, speaking, and understanding).

Additional Information:

Tasks, duties, and responsibilities listed are not exhaustive. The Company, at its sole discretion, may assign other tasks, duties, and responsibilities. Equivalent experience, skills, and/or education will be considered. Nothing contained herein should be construed to create an employment contract. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations.