Director of Biostatistics
Proclinical is currently recruiting for a Director of Biostatistics for a leading biotechnology company located in Boston, MA. As the Biostatistics Director, you will be involved in the design, execution, analysis, and reporting clinical studies across the company's development programs that are leveraging cutting-edge mRNA science to create transformative medicines for patients
- Serve as the biostatistics leader and point-of-contact in multiple clinical development teams responsible for determining clinical study strategies and delivering results with high quality and on time.
- Leader in bringing innovative statistical thinking and methods to help drive applications of suit-for-purpose statistical methods that enhance the probability of successes for clinical development programs.
- Collaborate with internal and external stakeholders to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data types.
- Develop statistical sections of clinical development plans, protocols, statistical analysis plans, and key specifications for statistical programming implementation of analyses.
- Plan, manage, and track biostatistics activities, timelines, and resources and assure operational excellence.
- Frequently interact with regulatory agencies and effectively address the statistical questions and requests.
- Review and/or author SOPs and/or Work Instructions related to biostatistics practices.
- Collaborate with and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals.
- Oversee statistical contractors / consultants and manage / mentor junior team members.
Skills and Requirements:
- PhD (or equivalent degree) with 6+ (for Associate Director) or 9+ years (for Director) of relevant work experience in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations. MS (or equivalent degree) with 9+ (for Associate Director) or 12+ years (for Director) of relevant experience.
- Excellent statistical knowledge with the ability of applying the knowledge to solve scientific and clinical problems.
- Working knowledge of relevant FDA, EU, ICH guidelines and regulations.
- Experience working with CROs, vendors, and relationship management preferred.
- Outstanding communication skills (verbal and written).
- Ability to manage multiple projects in a fast-paced environment.
- Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
If you are having difficulty in applying or if you have any questions, please contact Felix Hook at (+1) 646-367-2617 or email@example.com.
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.