Biostatistics Associate Director, Biostatistics Project Lead

Proclinical, in support of our client, are seeking an individual to fill the role of Biostatistics Associate Director, Biostatistics Project Lead, based in Cambridge, MA. The successful candidate will be responsible for all statistical aspects of the clinical development plan.

Responsibilities

• Provide input into product development strategy by suggesting innovative designs and decision-making tools.
• Select appropriate statistical methods for design of clinical trials and analysis of clinical study data.
• Oversee execution of statistical analyses, reviews statistical outputs and guarantee results interpretation.
• Review and approve statistical methods and results sections for clinical study reports (CSR).
• Review regulatory documents such as CSRs, as well as integrated reports and summary documents.
• Interact with regulatory authority personnel on clinical trial statistical issues.
• Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package. Ensure statistical representation at regulatory or other external meetings.
• Oversee statistical support to multiple project teams.
• Work independently, or with other statistical departmental members or consultants, to develop effective statistical approaches applicable to project.
• Consult with the Medical Writer and Physician on the interpretation of clinical results.
• Review abstracts, posters, and manuscripts to support Medical Affairs.
• Lead or contribute to departmental process improvement initiatives and creation/revision of SOPs.
• Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOPs.
• Update procedures or practices as needed to remain in compliance.
• Contribute to the establishment and maintenance of common formats and templates for key Biostatistics documentation.
• Respond to regulatory inquiries for products undergoing registration and approved products.
• Plan and track project activities, timelines, across projects. Provide justification for planned resource needs. Seek to optimize resource utilization and capacity.

Skills And Qualifications

• MS in Biostatistics or closely related field is required; PhD in same strongly preferred.
• 8+ years of relevant experience, inclusive of Oncology and regulatory areas.
• Broad knowledge and superior understanding of advanced statistical concepts and techniques
• Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs.
• Working knowledge of statistical analysis plans.
• Must have a working knowledge of all appropriate relevant regulatory guidance documents.
• Direct regulatory filing experience is required.
• Proficiency in SAS is strongly preferred.

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 Brandon Zheng at (+1) 646-851-0869 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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