Director Biostatistics

Statistical Science Director

As a Statistical Science Director , you'll leverage your extensive experience in the pharmaceutical industry to independently guide statistical strategies and technical activities. Whether it's designing, delivering, or interpreting data for high-level governance committees or regulatory submissions, your expertise will be pivotal. You'll also have the opportunity to be recognized externally as a methodology expert, leading technical analyses and mentoring less experienced staff. Join us and collaborate across functions to make a real impact!

What you'll do:

In this role you will be responsible in leading the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation for indications/projects within a product team.

You will provide leadership to statistical staff on the indications/projects so that all work is carried out with regards to clients standards and external regulations; through partnership with experts, developing design options and providing high quality decision support to enable the business to make informed decisions; quantifying the benefit, risk, value and uncertainty of the emerging product profile.

You will apply expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration. You will mentor/coach and support the education and training of statistics staff in the technical arena.

The accountabilities for supporting projects directly include:

• Lead the statistical design and strategy to product development plans, preclinical studies, regulatory strategy, health technology assessment, and/or commercial activities as appropriate for the stage of the product.
• Lead the statistical content and ensure quality for study designs, documents, delivery, interpretation, and submission.
• Quantify the benefit, risk, value, and uncertainty of the emerging product profile and communicate these effectively within the team.
• Provide global leadership to others and direct project work delivered by internal and external staff.
• Partner with CROs to ensure delivery to quality and time.
• Represent company externally which may include health authorities, advisory boards, conferences, workshops, and/or payer interactions.
• Maintain knowledge of statistical methodology in relevant areas and promote, investigate, and implement novel statistical approaches.
• Represent statistical strategy and decision-making at internal governance including review boards, therapy area leadership teams, and ESPC/LSPC.
• Mentor/coach and support the technical education and training of Statistics staff.

The accountabilities for supporting statistical methodological advances are (technical focus):

• In-depth knowledge of technical/regulatory requirements with experience in pharma/healthcare.
• Stay up-to-date and implement novel statistical approaches.
• Experience with and broad awareness of regulatory interactions and/or submissions.
• Excellent communication skills/build strong relationships.
• Nationally recognized externally. Invited to attend or speak at seminars and external meetings. Well-rounded statistician with publications on a range of topic areas. Publications resulting from external collaborations.
• Expert Leadership role able to lead/direct work across a team.

What we’re looking for:

This role requires an individual with outstanding technical skills, leadership, and the ability to guide and support multiple studies while fostering team development and project success.

Essential Skills/Experience:

• MSc/PhD in Statistics, Mathematics (with a substantial statistical component), or a recognized equivalent to a stats MSc.
• Proven track record of independent leadership.
• 5 years of experience in clinical trials is critical for this role.
• Recognized for exemplary technical skills and expert leadership role or national recognition as a statistical technical expert.
• Demonstrated ability to provide cross-study support, overseeing, aligning, and providing technical support for multiple studies.