Proclinical is currently recruiting for a Director Biostatistician with a biopharmaceutical company located in New York, NY. Successful candidate will provide guidance and accountability for all statistical aspects of clinical studies and submissions, including quality, relevance and scientific validity to the regulatory & clinical organizations.
- Provide statistical leadership to program teams.
- Collaborate with clinical and regulatory teams to design strategic approach, draft clinical development plans (CDP) and individual protocols.
- Lead statistical analyses, preparation of the statistical methods and results sections for clinical study reports (CSR), and production of overall summaries.
- Review and approve key results and statistical conclusions.
- Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package.
- Serve as representative at regulatory and other external meetings.
- Maintain awareness of industry standards, regulatory requirements, departmental guidelines, and SOP's. Update procedures and practices as needed to remain in compliance with external industry and internal SOP standards.
- Advocate application of statistical thinking across Ovid cross-functional decision-making. Develop collaborative and productive relationships with individuals across other functional teams.
Skills and Requirements:
- PhD in biostatistics.
- Minimum 5 of years of hands-on biostatistics experience with at least 3 years in the biotech industry, including interactions with regulatory bodies.
- Experience in neuroscience or neurodevelopment a plus.
- 1-2 years of experience developing and managing working relationships with third parties, including, CRO's, consultant and the research community.
- Working knowledge of data management, SAS, and regulatory submission standards.
- Excellent interpersonal, written, verbal and presentation communication skills.
- Comprehensive knowledge and superior understanding of advanced statistical concepts and techniques.
- Proven ability to innovatively apply technical principles, theories, and concepts to clinical development and the research & development lifecycle.
- Record of accomplishment in previous submissions and interactions, with regulatory bodies and/or involvement in development of regulatory guidelines and requirements for drug development.
- In-depth understanding of the regulatory drug submission/approval process in the US and globally.
- Ability to work in a self-directed manner.
- Ability to travel as needed (estimated less than 10% time).
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 Nicole Aganon at (+1) 347-293-1161 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.
Proclinical Staffing is an equal opportunity employer.
Up to €70000.00 per annum
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