Executive Director, Biostatistics

This is a fully remote position, open to applicants in United Kingdom, +1 more country.

📋 Description

• Offer statistical consulting and guidance throughout the clinical development lifecycle.

• Provide statistical expertise in the design of clinical development programs and individual protocols.

• Enhance existing protocols and prepare submissions across various therapeutic areas and indications.

• Engage with clients and regulatory bodies, including representing clients during crucial regulatory meetings.

• Lead or participate in client meetings focused on innovative study designs, analytical concepts, and the presentation, discussion, and interpretation of study results.

• Deliver technical leadership and advise internal teams on advanced or innovative statistical designs, models, applications, and complex statistical issues in clinical trials.

• Draw in new business by acting as a Biostatistics expert and collaborating with Business Development, Medical, Solutions Consultants, and other departments.

• Contribute to proposal development and participate in bid defense meetings.

• Represent Parexel at client marketing and technical meetings while supporting lead generation through networking, public speaking, and thought leadership.

• Coordinate client or account activities for the department or function.

• Engage in committees and task force groups.

• Collaborate with senior departmental management to nurture the development of biostatisticians.

• Maintain a working knowledge of and ensure compliance with ICH Guidelines, Good Clinical Practices, regulatory agency requirements, and Parexel standard operating procedures.

• Participate in departmental meetings, training initiatives, and project team meetings.

• Cultivate effective relationships with departments, clients, and regulatory agencies.

⛳️ Requirements

• PhD in Statistics or a related field, or MS in Statistics or a related field.

• Extensive experience in the pharmaceutical industry, with a comprehensive understanding of clinical development and therapeutic areas.

• Direct consulting experience.

• Experience in designing and executing development programs for drugs, devices, or diagnostics.

• Proven track record of successful direct interactions with relevant regulatory agencies such as the FDA, EMEA, MHRA, PMDA, NMPA, or other local agencies.

• Experience with regulatory submissions and negotiations during the regulatory review process, including preparation for and participation in Advisory Committees.

• In-depth understanding of regulatory guidance and practices related to specific indications and the submission and approval process.

• Experience with conference presentations and manuscript authorship.

• Exceptional organizational, communication, negotiation, problem-solving, analytical, and consulting abilities.

• Technical leadership skills and the capacity to contribute to a high-performing team.

• Expertise in innovative trial designs, optimization of protocols and development programs, submission strategies, and regulatory interactions.

• Strong knowledge of drug, device, or diagnostic development across various therapeutic areas and indications.

• Comprehensive understanding of statistical models, applications, and statistical issues in clinical trials.

• Ability to collaborate across functions and effectively communicate complex statistical concepts to clients, internal teams, and regulatory authorities.

• Preferred: expertise across multiple therapeutic areas and indications.

• Preferred: experience advising on advanced or innovative statistical designs, models, and applications.

• Preferred: experience in supporting proposals, bid defense meetings, client presentations, public speaking, or thought leadership.

🏝️ Benefits

• Occasional travel, primarily within Europe.

• Applicable bonus plans or incentive structures for eligible positions.