Job Title:
Principal Biostatistician
Company:
Syneos Health
A fully integrated biopharmaceutical solutions organization supporting the development and commercialization of therapies, Syneos Health operates in over 110 countries with expertise across clinical development, medical affairs, and commercial services.
Location:
India (Remote/Flexible)
Job ID:
25003326
Updated:
May 2, 2025 (Today)
Job Summary:
The Principal Biostatistician serves as a senior statistical leader on projects, mentoring team members and ensuring delivery of high-quality statistical services across the clinical development lifecycle—from study design to final reporting. This role requires deep expertise in statistical analysis, leadership on complex studies or submissions, and effective cross-functional collaboration.
Key Responsibilities:
Mentor and train biostatistics staff; lead internal training sessions.
Serve as statistical lead across all phases of clinical trial support—from protocol development to CSR.
Develop/review Statistical Analysis Plans (SAPs) and mock-ups for TLFs.
Ensure quality control and accuracy of statistical deliverables.
Oversee programming specs and review annotated CRFs and database design.
Lead complex/multi-study projects, submissions, and interact with regulatory agencies.
Manage timelines and budgets, identifying out-of-scope work and escalating as needed.
Participate in DSMB/DMC activities as voting or non-voting biostatistician.
Collaborate with cross-functional teams and contribute to internal meetings.
Support business development (e.g., proposals, budgets, bid defense).
Ensure compliance with SOPs, ICH guidelines, and documentation standards.
Qualifications:
Required:
Graduate degree in Biostatistics or related field.
Extensive experience in clinical trials and leadership across projects.
Strong SAS programming and statistical design knowledge.
Comprehensive knowledge of ICH guidelines and regulatory frameworks.
Excellent communication and project management skills.
Fluent in English (written and verbal).
Preferred:
Experience with regulatory submissions (e.g., FDA, EMA).
About Syneos Health:
Syneos Health has supported 94% of novel FDA drug approvals and 95% of EMA-authorized products over the last five years. With a global presence and mission to accelerate therapy delivery, the company values innovation, collaboration, and inclusion.
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