Mgr Biostatistics

Parsippany, NJ - Pharmaceutical & Biotech - Hybrid - Part time

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Date Posted: 2/8/2024

Manager Biostatistics
Parsippany, NJ (Hybrid schedule 2/3 days onsite)

Responsible for managing and directing statistical programmers on a project, writing statistical sections for protocols, authoring statistical analysis plans, review and quality control of deliverables from the Biometrics department. Will oversee contract research organization (CRO) statistical work and is responsible for overseeing quality control of statistical deliverables from the CRO. Responsible for ensuring consistency of deliverables across studies in a program (a group of studies to support regulatory submission).

Responsibilities:
Writing statistical sections for protocols. Perform sample size calculations. Writing or reviewing statistical analysis plans for protocols. Researching statistical methodologies. Provide protocol training at investigator meetings. Provide statistical consulting for other departments in the company. Program statistical analyses. Represent the biostatistics department at internal and external meetings. Review and analyze data. Managing biostatistics departmental timelines and resources for clinical studies. Manage biostatistics CRO. Attend meetings with regulatory agencies.

Qualifications:
Master’s Degree in statistics, biostatistics or related area from accredited college or university required. Minimum 2 years of experience in biostatistics or related area. Candidates should have experience in analyzing data from: Efficacy, Parallel. Cross-over, Pharmacokinetic and Dose-response studies. Excellent verbal and written English communication skills. Demonstrated knowledge of pharmaceutical industry. Demonstrated understanding of drug/device development. Demonstrated knowledge of regulatory process and guidelines. Programming experience in SAS is required; experience in R is a plus. Proven understanding of standard operating procedures, process and quality control associated with biostatistics in the pharmaceutical industry.

Please contact Darren Gutowski at dgutowski@clarkdavis.com

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