Executive Director, Biostatistics

Highly Competitive Salary
  1. Permanent
  2. Statistics
  3. United States
Waltham, Massachusetts
Posting date: 13 May 2019
SS.JS.23314_1557762377

ProClinical, in support of our client, are seeking an individual to fill the role of Executive Director of Biostatistics, based in Waltham, MA.

Responsibilities

  • Develop, maintain and supervise a department which is competent to carry out the research aims of the company.
  • Effectively project the resources needs for an indication and make modifications as needed and estimate resource needs.
  • Liaise with other departments in negotiations.
  • Have a deep understanding of advanced clinical trial design and statistical analysis methodologies.
  • Make major contributions to clinical development strategies.
  • Provide statistical consultation to medical management.
  • Act as the leader of Biostats for a clinical development plan and effectively manage all the statistical aspects of CDP and protocol development; be able to coordinate the whole BDM efforts for the indication.
  • Manage the statistical aspects of the protocol design, statistical monitoring of the trial and analysis of the trials.
  • Solid understanding of regulatory requirements and good clinical practice guidelines.
  • Keep up to date on current statistical methodologies relating to drug development in particular.
  • Support the statistical needs outside the Clinical Department as needed.
  • Keep abreast of current scientific progress and actively develop and maintain relationships with outside experts.
  • Provide expert statistical advice regarding clinical development plans and regulatory submissions.
  • Assure that clinical trials are well designed and that clinical trial reports and summaries for regulatory authorities are timely and high quality.

Skills and Qualifications

  • Ph.D. (MS), Biostatistics or equivalent with at least 14 years of pharmaceutical, biotechnology, or equivalent experience.
  • Demonstrated organizational, verbal, written and interpersonal skills.
  • A deep understanding of advanced clinical trial design and statistical analysis methodologies, as well as clinical development methodologies and strategies.
  • Understanding of statistics in the clinical/regulatory environment and use of statistical software such as SAS.

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 Junis Citozi at (+1) 929-388-1650 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.

#LI-JC2

close