Stryker is seeking a Principal Biostatistician to support statistical leadership and provide expertise across clinical research programs in the Trauma and Extremities division.
Requirements
- MS or PhD in Statistics, Mathematics, or a related field.
- Minimum of 5 years of experience applying statistics to clinical trials (PhD) or 8 years (MS).
- At least 5 years of experience with SAS programming, including proficiency in macros, SQL, and advanced data manipulation.
- Strong knowledge of regulatory guidelines (FDA/CFR, ISO14155).
- Experience with electronic data capture (EDC) systems.
- Experience supporting publication of analysis results (e.g., abstracts, posters, manuscripts).
- Advanced knowledge of clinical trial design and statistical procedures (e.g., nonparametric analysis, survival analysis).
Responsibilities
- Provide timely and scientifically sound statistical expertise to clinical development projects.
- Develop Statistical Analysis Plans, including methodology, derived variables, data-handling rules, and mock tables/figures.
- Perform inferential analyses and contribute to clinical study reports (CSRs), including interpretation of results.
- Collaborate with cross-functional teams to optimize study designs, endpoints, and analysis strategies.
- Develop and validate SAS programs for data sets, tables, listings, and figures (TLFs).
- Support regulatory submissions and respond to statistical inquiries from authorities.
- Guide junior statisticians and programmers, providing mentorship and technical oversight.
Other
- MS or PhD in Statistics, Mathematics, or a related field.
- Minimum of 5 years of experience applying statistics to clinical trials (PhD) or 8 years (MS).
- Travel Percentage: 10%
- Ability to explain statistical concepts to non-statisticians and collaborate across disciplines.
- Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.
