Proclinical Staffing - Franklin Township, NJ
posted 14 days ago
Full-time - Mid Level
Remote - Franklin Township, NJ
About the position
The Contractor Biostatistician will focus on Early Clinical Development, implementing and executing methodological aspects of clinical studies. This role involves collaboration with cross-functional teams to design clinical experiments, analyze data, and interpret results to support drug development.
Responsibilities
- Implement and execute methodological aspects of clinical studies.
- Work alongside different teams to frame statistical approaches for drug development questions.
- Design clinical experiments and interventional studies.
- Analyze data and interpret results to support decision-making.
- Co-author clinical study protocols.
- Perform statistical analyses for interim and final reports.
- Support clinical study teams on statistical matters.
- Participate in the preparation of study protocols and amendments.
- Perform sample size calculations and write statistical methodology sections.
- Review case report forms and provide feedback.
- Develop statistical analysis plans and programming specifications.
- Validate analysis programs and review Tables, Figures, and Listings.
- Prepare statistical methods and results sections for clinical study reports.
- Provide statistical insight into study results and support the review/approval process.
Requirements
- PhD degree in statistics/biostatistics or related disciplines with 1 year relevant work experience OR MS with 3 years relevant work experience.
- Knowledge of drug discovery and development.
- Solid understanding of statistical analysis methodologies and clinical trial design.
- Ability to work productively in a fast-paced, collaborative environment.
- Strong critical thinking, communication, and presentation skills.
- Expertise in statistical software such as R, SAS, WinBUGS, STAN, and/or Matlab.
