Portage, MI, 49024, USA
4 days ago
Principal Biostatistician (Remote)
Stryker is seeking a **Principal Biostatistician** to support our Trauma and Extremities division. This is a remote role based anywhere in the US. As the **Principal Biostatistician** , you will provide statistical leadership and support across clinical research programs. As a key member of a multi-disciplinary team, this role is responsible for developing Statistical Analysis Plans (SAPs), performing data analysis, and interpreting results to support regulatory submissions, publications, and strategic business decisions. The ideal candidate will bring deep expertise in clinical trial design, SAS programming, and regulatory standards to drive high-quality, data-driven outcomes. **What you will 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 you need** **Required** + 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. **Preferred** + 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. ​ $115,600.00 - $245,800.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role. 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. Stryker is an EO employer – M/F/Veteran/Disability.
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