The Vice President Biostatistics provides statistical consulting, strategic advice and operational execution in drug development including submissions and approvals as well as successful reimbursement applications.
The VP Biostatistics serves as a Leader in innovative study designs for enterprise and growth accounts (Biotech) and actively promotes new business by participating in project proposals, bids and client presentations as appropriate.
Key activities of the VP Biostatistics entail: Offer world-class Biostatistics consulting and operational execution Provide consulting and guidance throughout the clinical development process Provide statistical expertise in designing clinical development programs, individual protocols, optimizing existing protocols, preparing submissions Interact with clients and regulatory authorities, including representation at key regulatory meetings on behalf of the client Work cross-functionally and attend internal and external meetings as a subject matter expert in Biostatistics Travel to, attend and actively contribute / lead all kind of client meetings as appropriate (e.g.
discussing innovative study designs, analysis concepts, presenting, discussing and interpreting study results) Support interventional and non-interventional studies and use of Real World Data (RWD) in the drug development process Review and participate in writing publications Provide strategic consulting in trial design optimization and execution, clinical program development, submission strategies and regulatory interactions in a broad range of therapeutic areas and indications Provide technical leadership, serve as an internal consultant and advise internal team on advanced and/or innovative statistical designs, models and applications, complex statistical issues and challenges in clinical trials, and regulatory guidance As a world-class expert in Biostatistics attract new business for Parexel Work closely with Business Development, Medical, Solutions Consultants and other Parexel functions and attend client meetings as a subject matter expert in Biostatistics Contribute to business development, e.g., by actively contributing to proposal development (in particular if complex statistical designs or analyses are part of the proposal), attending and preparing bid defense meetings for potential studies, programs of work and functional service providers.
Represent Parexel at client marketing and technical meetings as needed Participate in and contribute to project bids, including client presentations.
Provide on-going support to Portfolio Management, Business Development, and Business Operations groups Support efforts for generating business leads (client networking, public speaking, etc) Required skills and experience: Skills: Excellent organizational, communication, negotiation, problem-solving, analytical, and consulting skills Technical leadership and contribute to a high performing team.
Outstanding understanding of the drug, device or diagnostic development process Expertise in broad different therapeutic areas and indications Excellent understanding of delivery models and issues in clinical trials and strategies to avoid them.
Thorough understanding of regulatory guidance and practices pertaining to specific indications and also to submissions and approval processes Strategic awareness of our business environment Knowledge of the International pharmaceutical market and the services required by sales, marketing, and operational support to achieve success.
An ability to assess situations and make and carry through difficult decisions.
Advanced ability to successfully manage a full workload across multiple-projects Excellent interpersonal, verbal and written communication skills (including experience in making presentations at conferences, meetings, training sessions) Demonstrable experience of stakeholder/relationship management with a client focused approach to work.
Advanced ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Advanced ability to work in a matrix environment and to value the importance of teamwork Comprehensive knowledge of relevant software: Windows, Word, Excel, Outlook Knowledge and Experience : Significant experience in the pharmaceutical industry, with broad clinical development and therapeutic area knowledge Direct experience in consulting and project delivery.
Proven record and experience with development, execution, and implementation of research strategies in the pharmaceutical industry Demonstration of successful direct interactions with relevant regulatory agencies like FDA/EMEA/PMDA or other local agencies Experience with regulatory submissions and negotiations during the regulatory review process, including Advisory Committee preparation and participation.
Experience with conference presentation and manuscript writing Education: Bachelors' Degree in a natural sciences discipline is mandatory, a higher degree will be preferred.
Travel required mostly within Europe.
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