Job Title:
Senior Biostatistician
Company:
Syneos Health
A global biopharmaceutical solutions organization supporting drug development and commercialization. Operates in over 110 countries, with expertise in clinical development, medical affairs, and commercialization services.
Location:
India (Remote/Flexible)
Job ID:
25003325
Updated:
May 2, 2025 (Today)
Job Summary:
The Senior Biostatistician provides statistical leadership and support across clinical studies, ensuring high-quality deliverables throughout the project lifecycle. The role includes protocol development, SAP writing, data analysis oversight, and team coordination.
Key Responsibilities:
Manage statistical tasks from study protocol through to CSR.
Prepare SAPs and develop mock-ups for tables, listings, and figures.
Coordinate work of biostatistics and programming staff on projects.
Review CRFs, database design, and statistical deliverables.
Provide verification and quality control of statistical outputs.
Serve as the biostatistical representative on cross-functional teams.
Oversee scheduling, timelines, and proactively communicate risks.
Provide programming support and contribute to integrated analyses.
Participate in DMC/DSMB activities as non-voting biostatistician.
Maintain organized documentation ensuring inspection readiness.
Support business development activities including proposals and bid defenses.
Mentor junior biostatistics team members.
Qualifications:
Required:
Graduate degree in Biostatistics or related field.
Moderate experience in clinical trials or equivalent background.
Proficiency in statistical programming (e.g., SAS).
Understanding of statistical design, analysis, ICH guidelines, and regulatory processes.
Strong communication skills in English (written and spoken).
Preferred Skills:
Experience across full clinical trial lifecycle.
Ability to manage multiple projects simultaneously.
Exposure to regulatory agency interactions is a plus.
About Syneos Health:
Syneos Health has been involved in 94% of novel FDA drug approvals and 95% of EMA-authorized products over the last five years. With a commitment to inclusion, innovation, and career development, the company fosters a culture where people thrive.
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