Current jobs related to Lead Biostatistician - Brockton, Massachusetts - Softworld Inc

Job Title:
Principal Biostatistician

Job Location:
Remote

Onsite Requirements:
Oversight of CROs
Experience with submissions
Preferred experience in ophthalmology/devices

Job Overview:
This full-time position involves leading biostatistical efforts for all 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, facilitating a high-quality database for planned analyses.

3. Develop randomization strategies and schedules.

4. Draft statistical analysis plans and create templates for statistical summary reports, or supervise such tasks by CROs.

5. Participate in the selection of qualified CROs for outsourced studies, oversee the execution of work orders, and ensure the delivery of validated reports by CROs.

6. Support programming of summaries as needed.

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 required.

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