The Vice President of Biostatistics provides expert statistical consulting, strategic advice, and operational execution in drug development, including submissions, approvals, and reimbursement applications. This role involves leading innovative study designs for enterprise and growth accounts (Biotech) and actively promoting new business through project proposals, bids, and client presentations.
Key activities of the VP Biostatistics include:
1. Offering world-class biostatistics consulting and operational execution.
2. Providing guidance throughout the clinical development process.
3. Designing clinical development programs, protocols, and preparing submissions with statistical expertise.
4. Interacting with clients and regulatory authorities, representing the company at key meetings.
5. Participating in internal and external meetings as a biostatistics subject matter expert.
6. Traveling to and leading client meetings on study designs, analysis concepts, and results interpretation.
7. Supporting interventional and non-interventional studies, including use of Real World Data (RWD).
8. Contributing to publications.
9. Providing strategic consulting on trial design, clinical program development, and regulatory strategies across therapeutic areas.
10. Offering technical leadership and advising on complex statistical issues and regulatory guidance.
11. Attracting new business through expertise in biostatistics.
12. Collaborating with Business Development and other teams, attending client meetings as an expert.
13. Contributing to business development efforts, including proposal development and bid defense meetings.
14. Representing the company at client marketing and technical meetings.
15. Participating in project bids and client presentations.
16. Supporting Portfolio Management, Business Development, and Business Operations.
17. Generating business leads via networking and public speaking.
Required skills and experience include:
* Excellent organizational, communication, negotiation, problem-solving, analytical, and consulting skills.
* Technical leadership and team contribution.
* Deep understanding of the drug, device, or diagnostic development process.
* Expertise across multiple therapeutic areas and indications.
* Knowledge of clinical trial delivery models and strategies to mitigate issues.
* Understanding of regulatory guidance and submission processes.
* Strategic awareness of the pharmaceutical market and related services.
* Ability to assess situations and make difficult decisions.
* Capacity to manage multiple projects successfully.
* Strong interpersonal, verbal, and written communication skills, including conference presentations.
* Experience in stakeholder management with a client-focused approach.
* Ability to prioritize and manage varied tasks with attention to detail.
* Ability to work effectively in a matrix environment and value teamwork.
* Proficiency in Windows, Word, Excel, Outlook.
Knowledge and experience:
* Significant industry experience with broad clinical and therapeutic knowledge.
* Experience in consulting and project delivery.
* Proven ability in research strategy development and implementation.
* Experience with regulatory agency interactions (FDA, EMEA, PMDA).
* Experience with regulatory submissions, negotiations, and advisory committee participation.
* Experience in conference presentations and manuscript writing.
Education:
* Bachelor's degree in a natural sciences discipline is mandatory; higher degrees preferred.
Travel mostly within Europe required.
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