Statistical Science Director V&I

AstraZeneca • Gaithersburg, MD

8d • $188,000 - $282,000 • Hybrid

About The Position

Are you ready to lead and innovate in the world of clinical statistics?
As a Statistical Science Director at AstraZeneca, 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!
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 an AZ product team.
You will provide leadership to statistical staff on the indications/projects so that all work is carried out with regards to AZ 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.

Requirements

• 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.

Nice To Haves

• Experience in Vaccines & Immunotherapy is a strong asset but open to other therapeutic areas (TA).
• Implemented simulation programming for sample size calculations or interim analyses.
• Experience with business development opportunities, such as in-licensing, would be beneficial.
• Proficiency in programming languages such as SAS, R, and Python.
• Strong project management skills.
• Excellent communication skills, especially in relation to project management, ensuring effective cross-functional collaboration and stakeholder engagement.

Responsibilities

• 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 AstraZeneca 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.
• 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.

Benefits

• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• health, dental, and vision coverage in accordance with the terms of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Director