Sr. Staff Biostatistician at Stryker

Raleigh, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Neurovascular, BiotechIndustries

Requirements

Bachelor’s degree in Biostatistics, Engineering, Science, or related field
6+ years of experience in clinical biostatistics
Proficiency in SAS programming
Strong ability to communicate statistical concepts to non-statisticians
Experience with clinical trial data analysis, inferential statistics, and regulatory documentation
Preferred
MS or PhD in Statistics, Mathematics, or related field
4+ years in medical device, pharmaceutical, or biotech settings
Experience with SQL, SAS Macros, and electronic data capture (EDC) systems
Experience in R programming
Familiarity with ISO 14155, FDA guidance, and EU MDR requirements

Responsibilities

Lead statistical planning and analysis for clinical trials, including development of statistical analysis plans (SAPs) and interpretation of complex data
Design and validate SAS programs to generate clinical datasets, tables, listings, and figures (TLGs) in compliance with regulatory standards
Collaborate with cross-functional teams—including clinical scientists, regulatory affairs, and neurointerventional physicians—to optimize study design and endpoints
Perform inferential analyses and contribute to clinical study reports (CSRs), including interpretation of results
Provide statistical input for regulatory submissions (e.g., FDA, EU MDR)
Provide timely and scientifically sound statistical expertise to clinical development projects
Stay current with evolving regulatory guidance and statistical methodologies relevant to medical devices

Skills

SAS

Biostatistics

Statistical Analysis Plans

Clinical Trials

Inferential Statistics

SQL

SAS Macros

EDC

ISO 14155

FDA

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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