Senior Biostatistics Manager

Highly Competitive Salary
  1. Permanent
  2. Statistics
  3. United States
Durham, North Carolina
Posting date: 26 Mar 2019
SS.JS.22396_1553633931

ProClinical, in support of our client, are seeking an individual to fill the role of Senior Manager of Biostatistics, based in Durham, NC. The successful candidate will be responsible for the planning and delivery of statistical activities required to support the highest quality design, conduct and analysis of sponsored studies.

Responsibilities

  • Ensure the relevance and adequacy of statistical methods employed in sponsored clinical development activities and selected nonclinical studies.
  • Ensure clinical data conformance to relevant regulatory guidelines and GCPs.
  • Contribute to the formulation of clinical development strategies.
  • Participate in the selection, direction, and supervision/management of CRO/contract staff for performance of outsourced operational activities.
  • Participate in clinical development/product management teams in support of organizational objectives.
  • Participate in FDA and other regulatory agency meetings.
  • Participate in organization-wide process definition, creation, and implementation with a continuous focus on efficiency and productivity enhancement.
  • Monitor and evaluate relevant performance metrics.
  • Author and review relevant sections of critical documents.
  • Assume responsibility for accuracy of all data included in public corporate communications of clinical trial results.

Skills And Qualifications

  • PhD or MS in Biostatistics or related field and 5+ years' relevant experience.
  • SAS programming experience.
  • Proven expertise with the disciplines, practices and procedures that pertain to biostatistics and understanding of clinical data management processes.
  • Demonstrated knowledge of the clinical development process and of relevant regulatory guidelines and requirements
  • Excellent written, verbal, and interpersonal communication skills.
  • Experience in early phase clinical trials including understanding of clinical pharmacology endpoints.
  • Experience with data monitoring committees and\or study steering committees.
  • Experience in Bayesian statistics as well as frequentist statistics.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call James Stevens at (+1) 646-693-0610 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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