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Principal Biostatistician

Company: Thor Companies
Location: Raleigh
Posted on: November 11, 2019

Job Description:

This is a REMOTE position. Must be US based.

Our ideal Statistician for the role has a Ph.D. in Statistics with at least two years' experience in clinical drug development. You'll use your skills to actively provide statistical support to the Clinical Research and Development Department, contributing to efficient study design, preparing statistical consideration sections and providing input into other protocol sections. You're a skilled relationship builder who can work through conflict to achieve high quality results. You'll use your experience to provide recommendations on technical, quality and timeline issues. This is a great opportunity to broaden your skills within the pharmaceuticals industry as a Senior Statistician.

Objectives of this Role --- Actively provide statistical support to the Clinical Research and Development Department, contributing to efficient study design, preparing statistical consideration sections and providing input into other protocol sections.
Daily and Monthly Responsibilities --- Prepare statistical analysis plans including table shells. --- Analyze clinical trial data; work with programmers to provide tables, listings and graphs, including ad hoc validation. --- Review, synthesize, interpret and report analysis results, including ad hoc requests for analyses. --- Provide statistical input for the preparation of final study reports and other required documents, including manuscripts. --- Provide statistical support for integrated reports, submissions preparation, and post-submission activities. --- Provide project requirements to programmers. --- Manage outside CROs and consultants as needed. --- Escalates issues to functional management as necessary. --- Makes recommendations or resolves technical, quality, and timeline issues. --- Provides leadership. --- Provides continuous feedback to peers and leaders. --- Proactively seeks ways to gain broader experience and perspectives with focus on a robust professional development plan.

Knowledge and skills required --- Ph.D. or MS. in statistics with a focus on statistical methods appropriate for clinical trials. --- Experience in clinical drug development at least 2 years' experience for Ph.D. or 5 years for MS. --- Demonstrated skill in the analysis and reporting of clinical trials. --- Knowledge of statistical methodologies and statistical regulatory requirements. --- Knowledge of statistical computing software (e.g. SAS or R). --- Knowledge of MS Office products (Word, Excel, PowerPoint).
This is a REMOTE position. Must be US based.

Keywords: Thor Companies, Raleigh , Principal Biostatistician, Other , Raleigh, North Carolina

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