Senior Biostatistician
About The Position
The Biostatistician in this role provides study-level statistical expertise in support of the design, analysis, and interpretation of clinical trials through collaboration with other team personnel including clinical research, clinical operations, data management, and programming. This support includes statistical aspects of study design, protocol review, and preparation of statistical sections; preparation of the statistical analysis plan; oversight of tables/listings/figures development; interpretation of results to internal clinical and management personnel; and assistance in the preparation of publications and submissions of regulatory deliverables. In providing clinical trial support, this person will participate in management of external resources to ensure quality, timely, and cost-effective statistical deliverables.
Requirements
- Graduate degree in Statistics or a related quantitative field.
- MS degree or equivalent with 3+ years relevant industry experience; or PhD degree or equivalent.
- Experience with statistical computing software including SAS.
- Excellent oral and written communication skills, and strong interpersonal skills.
- Excellent problem-solving skills.
- Effective collaboration in cross-functional teams.
- Solid statistical background, with application to clinical trials preferred.
- Scientific curiosity, eagerness to grow in statistical knowledge and applications.
- Excellent team player.
- Excellent communication skills.
Responsibilities
- Represent the biostatistics function in supporting the design, analysis, and interpretation of clinical trials through collaboration with other functions including Clinical Research, Clinical Operations, Data Management, and Programming.
- Provide statistical input to clinical plans in support of product development, claims, and submissions.
- Provide statistical support to the development and review of study protocols, statistical analysis plans, and clinical study reports.
- Participate in oversight of biostatistics activities of external vendors to ensure quality and timeliness of statistical deliverables.
- Collaborate with clinical and other personnel in the creation of publications and manuscripts.
- Assist in support for interactions with and submissions to regulatory agencies.
- Ensure compliance with all statistical analysis and reporting procedures.
Benefits
- Competitive Benefit Package
- Paid Company Holidays
- Paid Vacation
- Volunteer Time
- Learning & Development Opportunities
- Kenvuer Impact Networks
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What This Job Offers
Job Type
Full-time
Career Level
Senior
