Senior Director, Biostatistics

ProClinical, in support of our client, are seeking an individual to fill the role of Senior Director of Biostatistics, based in Cambridge, MA. The successful candidate will lead and supervise the biostatistician group and provide support to project teams over multiple therapeutic areas.

Responsibilities

• Develop, maintain and supervise a department which is competent to carry out the research aims of the company.
• Facilitate the professional training and development of members of the department, and reviews and evaluates the performance.
• Project the resources needs for an indication and make modifications as needed and estimate resource needs.
• Liaise with other departments in negotiations such as timelines, deliverables, expectations, resources, etc. for Biostatistics.
• Provide statistical consultation to medical management, as required.
• Act as the leader of Biostats for a clinical development plan.
• Effectively manage all the statistical aspects of CDP and protocol development.
• Effectively manage the statistical aspects of the protocol design, statistical monitoring and analysis.
• Keep up to date on current statistical methodologies relating to drug development in particular
• Support the statistical needs outside the Clinical Department as needed.
• 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 submitted in a timely manner.

Skills and Qualifications

• D. (MS), Biostatistics or equivalent with at 14+ years of pharmaceutical or biotechnology experience.
• Solid understanding of regulatory requirements and good clinical practice guidelines.
• Understanding of advanced clinical trial design and statistical analysis methodologies, as well as clinical development methodologies and strategies.
• Understanding of advanced clinical trial design and statistical analysis methodologies and make major contributions to clinical development strategies.
• Understanding of statistics in the clinical/regulatory environment and use of statistical software such as SAS.
• Strong written, verbal, and interpersonal communication skills.

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.

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