Statistical Science Director

AstraZenecaGaithersburg, MD
3d$188,000 - $282,000

About The Position

Statistical Science Director Location: Gaithersburg The Statistical Science Director has sufficient experience working as a statistician in the pharmaceutical industry to be accountable and independently lead the statistical strategy or technical activities related to design, delivery and interpretation, high level internal governance committees and/or regulatory submissions of a project. This individual is able to lead, perform and communicate results of more technical analyses, and able to guide less experienced staff. Competent individual contributor with excellent cross-functional collaboration. Typical Accountabilities: The Statistical Science Director will typically lead a project. The accountabilities for supporting projects directly include: • Lead the statistical design and strategy to product development plans, clinical 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 and interpretation and submission • Quantify the benefit, risk, value and uncertainty of the emerging product profile and can 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 AZ 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 decision-making governance including review boards, therapy area leadership teams and internal governance committees • Mentor/coach and support the technical education and training of Statistics staff AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. To receive notifications about future job opportunities, go to the 'Internal Jobs' tab on the Talent Intelligence Platform and create a job alert. Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Requirements

  • MSc/PhD in Statistics, Mathematics (containing a substantial statistical component), or recognised equivalent to stats MSc 7+ yrs of experience of pharmaceutical development, data analysis and interpretation and experience of program design.
  • Track record of background in leading independently Experience with and broad awareness of regulatory interactions and/or submissions
  • Exemplary technical skills Excellent communication skills/ builds strong relationships

Nice To Haves

  • TA or disease area knowledge expertise
  • Exposure to business development opportunities (e.g.in licencing)
  • Project management skills
  • Proficiency in programming SAS and/or R and Python

Responsibilities

  • Lead the statistical design and strategy to product development plans, clinical 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 and interpretation and submission
  • Quantify the benefit, risk, value and uncertainty of the emerging product profile and can 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 AZ 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 decision-making governance including review boards, therapy area leadership teams and internal governance committees
  • Mentor/coach and support the technical education and training of Statistics staff
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