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Statistical Science Director
Statistical Science DirectorAstraZeneca • Gaithersburg, MD, United States
Statistical Science Director

Statistical Science Director

AstraZeneca • Gaithersburg, MD, United States
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Are you ready to lead and innovate in the world of clinical statistics? As a Statistical Science Director at AstraZeneca, you'll use your extensive experience in the pharmaceutical industry to independently lead statistical strategies and technical activities. Whether it's crafting, 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 authority, leading technical analyses and mentoring less experienced staff. Join us and collaborate across functions to make a real impact and contribute to life-changing medicines!

What you’ll do :

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

You will provide leadership to statistical staff on the vaccine 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.

  • Lead the statistical design and strategy for product development plans, preclinical studies, regulatory strategy, health technology assessment, and commercial activities.
  • Ensure quality in statistical content for study designs, documents, delivery, interpretation, and submission.
  • Quantify and communicate the benefit, risk, value, and uncertainty of emerging product profiles.
  • Provide global leadership and direct project work delivered by internal and external staff.
  • Partner with CROs to ensure timely and quality delivery.
  • Represent AstraZeneca externally at health authorities, advisory boards, conferences, workshops, and payer interactions.
  • Maintain knowledge of statistical methodology and implement novel approaches.
  • Represent statistical strategy at internal decision-making governance.
  • Mentor and support the technical education of Statistics staff.

Essential Skills / Experience :

  • MSc / PhD in Statistics, Mathematics (with substantial statistical component), or recognized equivalent.
  • Consistent track record of independent leadership.
  • Extensive clinical trials experience.
  • Recognized as a statistical technical expert.
  • Outstanding technical skills.
  • Demonstrated ability to provide cross-study support, overseeing, aligning and providing technical support for multiple studies.
  • Desirable Skills / Experience :

  • Expertise in vaccine therapeutic areas or disease areas.
  • Exposure to business development opportunities (e.g., in licensing) is beneficial.
  • Project management skills.
  • Proficiency in programming SAS, R, and Python.
  • When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and bold world.

    The annual base pay for this position ranges from $ 177,878 - $266,816 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department / team performance, and market factors.

    AstraZeneca offers an environment where your expertise can truly shine. Here, you'll be part of a community of dedicated scientists who are both encouraging and challenging. We embrace global opportunities across all Therapy Areas, pushing boundaries to deliver groundbreaking solutions. Our collaborative mindset ensures that every opinion is valued, fostering an inspiring learning environment where setbacks are seen as opportunities for growth. With countless learning opportunities and a dedication to making a profound impact on society and patients worldwide, AstraZeneca is where you can apply your skills in innovative ways.

    Ready to take the next step in your career? Apply now to join our dynamic team!

    Date Posted

    23-May-2025

    Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments / accommodations to help all candidates to perform at their best. If you have a need for any adjustments / accommodations, please complete the section in the application form.

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    Director Statistical • Gaithersburg, MD, United States

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