Principal Biostatistician at Syneos Health
About Syneos Health: Syneos Health is a leading integrated biopharmaceutical solutions organization, focused on accelerating the success of its customers. Through unique clinical, medical affairs, and commercial insights, Syneos Health aims to meet modern market demands and improve patient outcomes globally. With 29,000 employees across 110 countries, the company puts the customer and patient at the heart of everything it does.
Job Responsibilities:
Leadership and Mentorship:
Serve as a resource and mentor to biostatisticians, developing training materials and conducting training sessions.
Guide and support team members to ensure the high quality and timely completion of work.
Statistical Support and Collaboration:
Oversee and participate in statistical tasks throughout the project lifecycle, from protocol to Clinical Study Report (CSR).
Prepare and review Statistical Analysis Plans (SAPs), including mock-up displays for tables, figures, and listings.
Manage randomization schedules and contribute to clinical study reports as needed.
Collaborate with sponsors and other teams on the statistical aspects of clinical trials.
Quality Control and Verification:
Ensure the integrity of analysis datasets, tables, listings, and figures by reviewing programming specifications.
Participate in the verification and quality control of project deliverables to ensure consistency with the SAP.
Project Management:
Lead or manage complex or multiple projects, ensuring that timelines are met and milestones are achieved.
Proactively address any challenges with timelines or project scope, escalating issues when necessary.
Monitor progress, adjust resources, and ensure that deliverables are on track.
Regulatory and Data Monitoring:
Support regulatory agency meetings or respond to questions, representing the statistical analysis results.
Participate in Data Safety Monitoring Board (DSMB) and Data Monitoring Committee (DMC) activities, including serving as an independent non-voting or voting statistician as needed.
Business Development and Communication:
Contribute to proposals, budgets, and attend sponsor bid defense meetings to support business development efforts.
Communicate effectively with internal teams, presenting ideas, respecting others’ opinions, and providing statistical input as necessary.
Administrative and Documentation:
Ensure well-organized, up-to-date project documentation that is inspection-ready.
Maintain compliance with SOPs, regulatory guidelines, and quality control processes.
Qualifications:
Education:
Graduate degree in biostatistics or related discipline.
MS in statistics or biostatistics (less than 4 years of experience) or equivalent experience.
Experience:
Extensive experience in clinical trials or an equivalent combination of education and experience, with a proven ability to lead multiple projects.
Experience in the statistical analysis of clinical trials from protocol to CSR.
Familiarity with regulatory submissions and clinical research methodology is preferred.
Technical Skills:
Expertise in statistical methodology, particularly for clinical trial design and analysis.
Proficiency in scientific computing and programming (SAS, R, and Shiny) for statistical analysis, data manipulation, and visualization.
Knowledge of statistical design, analysis, and regulatory guidelines (e.g., ICH).
Communication Skills:
Strong written and verbal communication skills, with the ability to explain complex statistical concepts clearly.
Ability to work effectively across multiple departments and teams.
Why Syneos Health?
Career Development:
Syneos Health offers continuous professional growth, training, mentorship, and recognition for its employees.
Inclusive Culture:
The company promotes a diverse and inclusive workplace where everyone can bring their authentic selves to work.
Global Impact:
Syneos Health is deeply involved in the development of critical new therapies, having worked on 94% of novel FDA-approved drugs and 95% of EMA-authorized products.
Additional Information:
The job description is not exhaustive, and Syneos Health may adjust duties based on business needs. Equivalent experience and education may be considered for qualifications. The company complies with the Americans with Disabilities Act and offers accommodations as needed.
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Siliguri |Illinois :
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