Syneos Health
Manager Of Biostatistics
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Company Description
Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success across clinical, commercial, and real-world settings. The company brings together professionals with deep expertise in patient and physician behaviors, market dynamics, and advanced business practices to help deliver important therapies to patients more efficiently. Syneos Health leverages diverse insights and modern technologies to address evolving market realities and support innovative healthcare solutions. Team members work within an authentic, inclusive, and high-performance culture that prioritizes care for colleagues, customers, patients, communities, and the environment.
Role Description
The Manager of Biostatistics is a full-time remote role responsible for leading biostatistical activities across clinical studies and projects. This role typically oversees study design, sample size calculations, and statistical analysis plans, ensuring that methods align with regulatory and scientific standards. The Manager collaborates closely with clinical, data management, programming, and medical writing teams to interpret results, provide statistical input, and support protocol development and study reporting.
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Day-to-day responsibilities may include:
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- Reviewing and validating statistical outputs
- Mentoring biostatistics staff
- Contributing to process improvement initiatives
- Supporting interactions with sponsors and regulatory authorities
The person in this role is expected to manage timelines and quality for multiple projects while promoting best practices in biostatistics across the organization.
Qualifications
- Expertise in biostatistics and clinical trial methodology, including study design, sample size estimation, and interpretation of clinical data.
- Proficiency with statistical software and tools commonly used in clinical research (e.g., SAS, R) and familiarity with data management and programming workflows.
- Knowledge of relevant regulatory guidelines and standards (e.g., ICH, FDA, EMA) and experience supporting submissions or regulatory interactions.
- Strong leadership and people management skills, with experience mentoring biostatisticians and coordinating cross-functional project teams.
- Excellent written and verbal communication skills for explaining complex statistical concepts to diverse stakeholders and contributing to protocols, reports, and publications.
- Demonstrated ability to work independently in a remote environment, manage multiple priorities, and meet project deadlines with high-quality deliverables.
- Master’s or PhD in Biostatistics, Statistics, or a related quantitative field; prior experience in biostatistics within the biopharmaceutical or CRO industry is highly beneficial.
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