Senior Director, Biostatistics
The Global Life Science Hub are partnered with a very up-and-coming, niche, full-service Contract Research Organisation specialising in Rare Oncology diseases. This company of 1200 employees globally are partnered with some of the most unique and ground-breaking Biotech companies known in the industry.
With a solid 30% growth in 2022, it has seen a considerable increase in its Biometrics requirements leading to the appointment of a Senior Director of Biostatistics who will be responsible for the successful operations of the Biostatistics department, overseeing the statistical aspects of projects and project teams through the management of department managers, internal staff, and interaction with Executive-level staff.
- Responsible for the direct management of Biostatistics Management and indirect management of all Biostatistics staff, including hiring, resourcing, personnel development, growth, training, employee relations, and leading department meetings
- Responsible for providing strategic direction and leadership to the Biostatistics team to best achieve departmental and company goals.
- Interacts with clients to provide a high standard of customer service and ensure complete understanding of the Biostatistics capabilities
- Interacts with Strategic Consulting, Regulatory Affairs, and Project Management teams to provide a high standard of consultation on issues related to the design, analysis, and interpretation of clinical trials in a variety of therapeutic areas
- Attend meetings with scientific advisory groups and regulatory bodies, as needed, to support statistical aspects of regulatory submissions on behalf of sponsors
- Serve as a thought leader by staying abreast of the latest developments in the field of statistics in drug development.
- maintain and improve professional knowledge of technological advancements in data manipulation and statistical analyses;
- Plan, coordinate, and provide statistical analyses, summaries, and reports of studies in the support of product development including IND / NDA and BLA submissions, and IDE and PMA submissions
- Participate in business development activities, including proposal generation, presentations of capabilities, and bid defences
- Participate in governance meetings with Sponsors, and establish relationships with Sponsor peers
- Leads by example and models core values in all actions; ensures a positive, respectful team environment, fostering collaboration and development
- PhD in statistics/biostatistics is highly preferred but MSc is satisfactory
- Must have at least 10 years of relevant life science work experience
- 3 years minimum of supervisory experience, preferably in a CRO environment
- Must have extensive FDA experience
- Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies
The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com