Clinical Statistician II - C
- Provide statistical input for study design, protocols, CRFs, and statistical analysis plans (SAPs).
- Ensure statistical components of clinical studies support product performance and validation claims.
- Set up and maintain study directories and analysis programming environments.
- Collaborate with Data Management and Clinical Affairs to support study data processing and integrity.
- Perform complex data checks and resolve data quality issues in collaboration with cross-functional teams.
- Develop SAS programs to generate tables, listings, and figures for clinical and verification studies.
- Participate as a statistical subject matter expert on project teams, clearly communicating statistical concepts.
- Support data review activities and preparation of regulatory submissions.
- Perform program verification and related tasks as assigned.
- Work independently on routine issues and escalate critical items in a timely manner.
- Maintain compliance with FDA regulations, company policies, and quality system requirements.
- Master’s degree in Statistics or a related field with 2–3 years of relevant experience.
- Strong experience in statistical analysis, statistical writing, and SAS programming.
- Hands-on experience supporting clinical or verification studies.
- Master’s degree with 2–3 years of experience or PhD in Statistics or a related field.
- Prior experience in clinical statistics, preferably within medical device studies.
- Extensive experience with SAS; familiarity with R or other statistical programming tools is a plus.
- Experience working in a highly regulated environment.
- Strong ability to manage multiple priorities, timelines, and deliverables.
- Excellent organizational, time management, and attention-to-detail skills.
- Effective verbal and written communication skills, with the ability to explain complex statistical concepts clearly.
- Ability to work independently and collaboratively in cross-functional teams.
- Statistical Analysis Plans (SAPs)
- Clinical Study Design & Data Analysis
- SAS Programming (Tables, Listings, Figures)
- Regulatory Compliance (FDA)
- Data Integrity & Data Management
- Regulatory Submissions & Data Review
- Medical Device Clinical Studies
- Cross-Functional Collaboration
- Problem Solving & Independent Work
- Strong Communication & Documentation Skills
- Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- Health Savings Account (for High Deductible Health Plans)
- Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
- Supplemental Life Insurance
- Short Term Disability (coverage varies by state)
- Long Term Disability
- Critical Illness, Hospital coverage, Accident Insurance
- MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
- 401(k)
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