Biostatistician
About The Position
The Biostatistician partners with clinical investigators and research teams to design robust clinical studies, select appropriate statistical methodologies, and determine sample sizes that support clinical utility. The role authors statistical analysis plans (SAPs) and statistical reports for health authority review and scientific evaluation. It performs data analyses, coordinates sample randomization and blinding, and oversees peer quality reviews to maintain data integrity. The position also identifies and applies statistical methods and study-design improvements for complex diagnostic-development challenges. It takes ownership of major diagnostic project deliverables, coaches team members, and shares scientific contributions through publications, conference presentations, and cross-functional workshops.
Requirements
- Master’s degree in Statistics, Biostatistics, or a closely related quantitative field with at least 9 years of relevant experience, or a PhD with at least 6 years of relevant experience.
- Hands-on proficiency in statistical programming with SAS or R.
- Experience in statistical analysis and reporting for diagnostic validation or clinical studies.
- Practical understanding of regulatory considerations for in vitro diagnostic devices, including sensitivity, specificity, agreement rates, and reproducibility evaluations.
- Ability to collaborate in multidisciplinary teams, align cross-functionally, and coordinate quality control.
- Ability to communicate statistical concepts clearly to diverse scientific audiences.
Nice To Haves
- Technical presentations, white papers, or publications demonstrating scientific communication.
Responsibilities
- Collaborate with clinical investigators and research partners to design clinical studies, choose statistical methodologies, and determine sample sizes.
- Write statistical analysis plans and statistical reports for health authority review and scientific evaluation.
- Perform data analyses and coordinate sample randomization and blinding procedures.
- Oversee peer quality reviews to uphold data integrity.
- Identify, develop, and apply statistical solutions and study-design improvements for diagnostic development.
- Own major diagnostic project deliverables and coach team members.
- Represent the team’s scientific contributions through technical publications, conference presentations, and cross-functional workshops.
Benefits
- A discretionary annual bonus may be available based on individual and company performance.
- Relocation benefits are not available for this position.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
