Principal Biostatistician at Syneos Health
About Syneos Health:
Syneos Health is a leading, fully integrated biopharmaceutical solutions organization that accelerates customer success. The company focuses on bringing the customer and patient to the center of everything it does. Syneos Health is committed to simplifying and streamlining processes to be easier to work with and for. With over 29,000 employees across 110 countries, Syneos Health helps deliver therapies that change lives.
Job Responsibilities:
Leadership & Mentorship:
Serve as a resource within the statistical department, mentoring junior biostatisticians and overseeing their development.
Conduct training sessions and create training materials for Biostatistics associates.
Project Management & Execution:
Oversee and guide statistical work on assigned projects to ensure timely, high-quality deliverables.
Prepare and review Statistical Analysis Plans (SAPs) and mock-up displays for tables, listings, and figures.
Provide independent reviews of project work and ensure consistency with SAPs.
May serve as the Lead Biostatistician, handling the statistical aspects of protocols, randomization schedules, and clinical study reports.
Statistical Support & Analysis:
Provide statistical input across all project phases, from protocol development to the Clinical Study Report (CSR).
Review and prepare programming specifications for datasets, tables, listings, and figures.
Perform verification and quality control of project deliverables to meet the expected results.
Regulatory & External Communication:
Lead regulatory submissions and attend meetings to represent statistical findings.
Serve as a non-voting biostatistician for Data Safety Monitoring Boards (DSMB) or Data Monitoring Committees (DMC).
Business Development & Client Interaction:
Contribute to proposals, budgets, and attend sponsor bid defense meetings.
Assist in identifying out-of-scope tasks and escalate issues to management.
Time Management & Scheduling:
Manage scheduling and timelines across multiple projects.
Proactively communicate time constraints or issues with biostatistics management to meet deadlines.
Qualifications:
Education:
Graduate degree in biostatistics or related field.
MS in statistics or biostatistics, or closely related scientific field (4+ years of experience).
Experience:
Extensive experience in clinical trials or equivalent, demonstrated by the ability to lead multiple projects.
Proficiency in statistical programming tools like SAS, R, and Shiny.
Experience with statistical methodologies, regulatory guidelines, and programming in clinical research.
Experience in assay development, drug safety studies, and regulatory submissions is a plus.
Skills:
Ability to apply statistical knowledge to design, analyze, and interpret clinical trial data.
Proficient in programming and implementing advanced statistical analysis.
Strong communication skills, both written and verbal.
Ability to work independently and collaborate effectively with cross-functional teams.
Other:
Ability to understand and apply regulatory guidelines (e.g., ICH).
Strong organizational skills and attention to detail.
Ability to travel as required (minimal).
Why Syneos Health?
Career Development:
Opportunities for growth through supportive management and peer recognition programs.
Inclusive Culture:
Commitment to a Total Self culture that celebrates diversity and encourages authenticity.
Global Impact:
Work with leading biopharmaceutical companies to accelerate drug development and help deliver therapies that change lives.
Additional Information:
Syneos Health offers flexibility in assigning roles based on equivalent experience, and the company is committed to compliance with the Americans with Disabilities Act and other relevant legislation.
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