Principal Biostatistician

Job Title: Principal Biostatistician

Job Location: Bridgewater NJ 08807 Remote

Onsite Requirements:

Oversight of CROs
Submissions experience
Ophthalmology/Device experience is preferred but not required

Job Description:

The position is a full-time sponsor lead biostatistician supporting all phases of clinical trials of medical devices and pharmaceuticals.

Responsibilities:

Collaborate on protocol development including the design of the study, clarification of endpoints to meet objectives, calculation of power and sample size, and writing statistical sections
Review case report forms to ensure capturing of all required data in a way that supports a high-quality database for the planned analyses
Create randomization strategies and schedules
Write statistical analysis plans, create summary templates and specifications for statistical summary reports, or oversee such work and implementation by CROs.
Participation in selection of qualified CROs for outsourced studies, oversee implementation of work orders, and delivery of validated reports by CROs
Support programming of summaries as necessary
Write/review statistical and outcome sections of study reports and submissions
Assess feasibility of analysis requests and associated timelines
Communicate/discuss data/analysis issues with team of programmers (SAS and
Data Management), statisticians, and clinical managers
Serve as technical resource to study teams
Ensure CDISC/SDTM datasets and define documents are appropriately prepared for submission
Assist in defending strategy and findings to FDA and other regulatory bodies
Appropriately plan for and execute ad hoc analyses