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Lead Biostatistician for Clinical Trials
2 months ago
Job Title:
Principal Biostatistician
Job Location:
Remote
Onsite Requirements:
Oversight of CROs
Experience with submissions
Preferred experience in ophthalmology/device but not mandatory
Job Overview:
This role involves a full-time commitment as a lead biostatistician, primarily focusing on supporting various phases of clinical trials related to medical devices and pharmaceuticals.
Key Responsibilities:
1. Collaborate on the development of protocols, including study design, endpoint clarification to meet objectives, power and sample size calculations, and drafting statistical sections.
2. Review case report forms to ensure all necessary data is captured, supporting a high-quality database for planned analyses.
3. Develop randomization strategies and schedules.
4. Draft statistical analysis plans, create summary templates, and specifications for statistical summary reports, or supervise such tasks and their execution by CROs.
5. Participate in the selection of qualified CROs for outsourced studies, oversee the implementation of work orders, and ensure the delivery of validated reports by CROs.
6. Provide support for programming summaries as required.
7. Write and review statistical and outcome sections of study reports and submissions.
8. Evaluate the feasibility of analysis requests and their associated timelines.
9. Communicate and discuss data and analysis issues with a team of programmers (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 properly prepared for submission.
12. Assist in defending strategies and findings to regulatory bodies.
13. Plan and execute ad hoc analyses as needed.
