Stryker Corporation is seeking a Principal Biostatistician to provide statistical leadership and support for clinical research programs within its Trauma and Extremities division. In this role, you will be responsible for developing Statistical Analysis Plans, performing data analysis, interpreting results, and supporting regulatory submissions and strategic business decisions.
What You'll Do
- 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.
- Stay current with statistical methodologies, regulatory guidance, and programming tools through ongoing learning.
What We're Looking For
- 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.
Nice to Have
- 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).
- Ability to explain statistical concepts to non-statisticians and collaborate across disciplines.
Technical Stack
- SAS
- SAS macros
- SQL
Team & Environment
Key member of a multi-disciplinary team.
Benefits & Compensation
- Salary plus bonus eligible + benefits.
- Compensation range: $115,600.00 - $245,800.00.
Work Mode
This is a hybrid position based in the US.
Stryker Corporation is an equal opportunity employer. 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.
