Parexel Uxbridge, England, United Kingdom
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The Vice President of Biostatistics provides strategic consulting, operational execution, and expert guidance in drug development, including submissions, approvals, and reimbursement processes. This role involves leading innovative study designs for enterprise and growth accounts (Biotech) and actively engaging in business development through project proposals, bids, and client presentations.
Key Responsibilities:
* Deliver world-class biostatistics consulting and operational support
* Guide clinical development processes and design protocols
* Support regulatory submissions and interact with authorities
* Engage with clients and internal teams as a subject matter expert
* Lead client meetings discussing study designs and results
* Support studies using Real World Data (RWD)
* Contribute to publications and scientific communications
* Provide strategic trial design and development advice
* Offer technical leadership on statistical models and regulatory guidance
* Attract new business through expert contributions and networking
* Participate in proposals, bids, and client presentations
Required Skills and Experience:
* Strong organizational, communication, negotiation, and problem-solving skills
* Technical leadership and team contribution abilities
* Deep understanding of drug, device, or diagnostic development
* Expertise across various therapeutic areas
* Knowledge of clinical trial delivery models and regulatory practices
* Strategic business awareness and market knowledge
* Ability to manage multiple projects effectively
* Excellent interpersonal and presentation skills
* Experience in stakeholder management and client relations
* Proficiency with relevant software: Windows, Word, Excel, Outlook
Knowledge and Experience:
* Extensive pharmaceutical industry experience and clinical development knowledge
* Proven consulting and project delivery success
* Experience with regulatory agencies like FDA, EMA, PMDA
* Background in regulatory submissions and negotiations
* Experience in scientific presentations and manuscript writing
Education:
* Bachelor’s Degree in a natural sciences discipline required; higher degrees preferred
Additional Details:
* Seniority level: Executive
* Employment type: Full-time
* Job function: Research, Science, and Analyst
* Industry: Pharmaceutical Manufacturing
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