Lead Biostatistician

2 weeks ago

Brockton, Massachusetts, United States Softworld Inc Full time

Position Title:
Principal Biostatistician

Location:
Remote

Onsite Responsibilities:
Oversight of Contract Research Organizations (CROs)
Experience with regulatory submissions
Preferred background in ophthalmology or medical devices

Position Overview:
This role encompasses a full-time position as a lead biostatistician, providing support across all stages of clinical trials involving medical devices and pharmaceuticals.

Key Responsibilities:
1. Collaborate on the development of study protocols, including designing the study framework, clarifying endpoints to align with objectives, calculating power and sample size, and drafting statistical sections.
2. Review case report forms to ensure all necessary data is captured effectively, contributing to a high-quality database for subsequent analyses.
3. Develop randomization strategies and schedules.
4. Author 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 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 prepared appropriately for submission.
12. Assist in defending strategies and findings to regulatory bodies.
13. Plan and execute ad hoc analyses as needed.

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