Lead Biostatistician
2 weeks ago
Position Title:
Principal Biostatistician
Location:
Remote
Onsite Expectations:
Oversight of Contract Research Organizations (CROs)
Experience with submissions
Preferred experience in ophthalmology or medical devices
Position Overview:
This role is a full-time lead biostatistician position, responsible for supporting various phases of clinical trials related to medical devices and pharmaceuticals.
Key Responsibilities:
1. Collaborate on the development of study protocols, including:
a. Designing the study
b. Clarifying endpoints to align with objectives
c. Calculating power and sample size
d. Drafting statistical sections
2. Review case report forms to ensure comprehensive data capture for high-quality databases.
3. Develop randomization strategies and schedules.
4. Draft statistical analysis plans and create templates for statistical summary reports, or supervise these tasks performed by CROs.
5. Participate in the selection of qualified CROs for outsourced studies, oversee the execution of work orders, and ensure timely delivery of validated reports.
6. Provide programming support for summaries as needed.
7. Write and review statistical and outcome sections of study reports and submissions.
8. Evaluate the feasibility of analysis requests and associated timelines.
9. Communicate and discuss data and analysis issues with programming teams (SAS and Data Management), statisticians, and clinical managers.
10. Serve as a technical resource for study teams.
11. Ensure that CDISC/SDTM datasets and define documents are prepared appropriately for submission.
12. Assist in defending strategies and findings to regulatory bodies.
13. Plan and execute ad hoc analyses as required.
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