About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. 

We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart®. 

About the Role

We are seeking an Executive Director, Biostatistics (Scientific Advisory) to join our team in a remote capacity based in United Kingdom or Ireland. As Executive Director, Biostatistics, you will provide statistical consulting and strategic advice on optimal study designs and analyses across drug, device, and diagnostic clinical development, including preparation for regulatory authority interactions. You will serve as a leader in innovative study designs for client accounts and support new business through project proposals, bids, and client presentations. 

This role offers the opportunity to shape clinical development programs, guide complex statistical strategy, and represent clients in important regulatory discussions. You will work across functions as a trusted Biostatistics subject matter expert, strengthen client partnerships, and help advance high-quality clinical research through innovative and practical statistical solutions. 

Key Responsibilities

• Provide statistical consulting and guidance throughout the clinical development process. 

• Provide statistical expertise in the design of clinical development programs and individual protocols, optimize existing protocols, and prepare submissions across a broad range of therapeutic areas and indications. 

• Interact with clients and regulatory authorities, including representing clients at key regulatory meetings. 

• Lead or actively contribute to client meetings focused on innovative study designs, analysis concepts, and the presentation, discussion, and interpretation of study results. 

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

• Attract new business for Parexel by serving as a Biostatistics expert and partnering with Business Development, Medical, Solutions Consultants, and other Parexel functions. 

• Contribute to proposal development and prepare for and attend bid defense meetings for potential studies or partnerships. 

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

• Coordinate client or account activities for the department or function, as assigned, and participate in committees and task force groups as needed. 

• Partner with senior departmental management to develop biostatisticians. 

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

• Participate in departmental meetings, training initiatives, and project team meetings while maintaining effective relationships with other departments, clients, and regulatory agencies. 

Candidate Profile

You'll thrive in this role if you bring: 

• Excellent organizational, communication, negotiation, problem-solving, analytical, and consulting skills 

• Technical leadership and the ability to contribute to a high-performing team 

• Expertise in innovative trial designs, protocol and development program optimization, submission strategies, and regulatory interactions 

• A strong understanding of drug, device, or diagnostic development across different therapeutic areas and indications 

• A thorough understanding of statistical models, applications, and the statistical issues that can arise in clinical trials 

• The ability to collaborate across functions and communicate complex statistical concepts credibly to clients, internal teams, and regulatory authorities 

Required Qualifications

• PhD in Statistics or a related discipline, or MS in Statistics or a related discipline 

• Significant experience in the pharmaceutical industry, with broad clinical development and therapeutic area knowledge 

• Direct consulting experience 

• Experience designing and executing drug, device, or diagnostic development programs 

• Demonstrated successful direct interactions with relevant regulatory agencies such as FDA, EMEA, MHRA, PMDA, NMPA, or other local agencies 

• Experience with regulatory submissions and negotiations during the regulatory review process, including Advisory Committee preparation and participation 

• Thorough understanding of regulatory guidance and practices related to specific indications and the submission and approval process 

• Experience with conference presentations and manuscript writing 

Preferred Qualifications

• Expertise across multiple therapeutic areas and indications 

• Experience advising on advanced or innovative statistical designs, models, and applications 

• Experience supporting proposals, bid defense meetings, client presentations, public speaking, or thought leadership 

Additional Information

• Occasional travel is required, mostly within Europe. 

Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.