Senior Director, Biostatistics

AstraZeneca•Boston, MA

1d•$221,036 - $331,554•Hybrid

About The Position

This Senior Director, Biostatistics role leads a global team of statisticians to shape the design, delivery and interpretation of clinical programs, internal governance decisions and regulatory submissions. The work focuses on bringing rigorous statistical thinking to rare disease drug development, from early strategy through to reimbursement and commercialisation. How will your expertise in biostatistics influence the next generation of life-changing medicines? You will be responsible for: Lead, manage and develop a group of statisticians Leadership to biostatistics staff world-wide Ensures drug projects are successfully delivered by leading biostatistics support and strategy. This includes Development Plans, Regulatory Strategy and Submissions, high level internal governance committees, Health Technology Assessment and Reimbursement/Payer and Commercial support as appropriate for the stage of the product. Leadership to staff on the product world-wide so that all work is carried out with regards to Alexion standards and external regulations Develop contacts with international and external opinion leaders, consultants, and collaborative groups Provide leadership and direction to improvement projects/activities/initiatives Identify & drive the development & utilization of leading-edge statistical methodology, skills, capabilities, tools, processes & best practice, in order to add value to drug development Lead biostatistics resourcing to deliver projects and input on internal vs outsourcing delivery Maintain understanding and awareness of, as well as investigate and implement, new methodologies, therapy area and development advances May represent Alexion and biostatistics to Health Authorities and Reimbursement/Payer Organizations or high level internal governance committees for specific projects/indications Competent program and project leadership Work according to agreed functional and regional Safety, Health, and Environment (SHE) strategy by ensuring proper management of SHE risks, incidents, reporting, follow-up and improvements Duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. When we put unexpected teams in the same room, we unleash 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 outstanding and ambitious world. At AstraZeneca’s Rare Disease unit, work is driven by the lived experiences of people with rare and devastating conditions, keeping patients at the centre of every decision. Teams combine the agility of a biotech with the reach of a global biopharmaceutical company. They build space to experiment, learn quickly, and apply innovative science where unmet needs are high. Colleagues collaborate across disciplines and geographies, supported by leaders who invest in development and encourage speaking up, curiosity and new ideas. Every project offers the chance to turn rigorous science into meaningful change for individuals, their families and their communities. If this opportunity resonates and your expertise matches what we are looking for, apply now to explore the next step in your career with us. For over three decades, patients and their caregivers have been at the center of everything we do. Every day, we are inspired to follow the science and think differently to create better outcomes for them and their families. Our mission is driven by understanding who they are as unique individuals, not solely defined by their diseases. We’re a leading rare disease company with a diversified projects. Our pioneering legacy in rare diseases is rooted in being the first to translate the complex biology of the complement system into transformative medicines over the past three decades. Today, we continue to push the boundaries of science and deepen our understanding of rare diseases with patient-centricity at the core. This knowledge allows us to innovate and evolve into new areas where needs are unmet and provide an opportunity to help people fully live their best lives.

Requirements

MSc/PhD in Statistics, Mathematics (containing a substantial statistical component), or recognized equivalent to stats MSc
Track record of background in leading independently
In depth knowledge of technical/regulatory requirements with 10 years experience in pharm/healthcare
Exemplary technical skills
Excellent communication skills and ability to build strong relationships
Flexible, well-organized, and possess the ability to work well under pressure

Nice To Haves

PhD in Statistics/Biostatistics is preferred.
Managerial experience
Excellent collaboration required – needs the energy to work across global & functional boundaries both internally and externally
Vision – keen awareness of R&D priorities in order to apply novel solutions to scientific problems
Travel – willingness to travel domestically & internationally

Responsibilities

Lead, manage and develop a group of statisticians
Leadership to biostatistics staff world-wide
Ensures drug projects are successfully delivered by leading biostatistics support and strategy. This includes Development Plans, Regulatory Strategy and Submissions, high level internal governance committees, Health Technology Assessment and Reimbursement/Payer and Commercial support as appropriate for the stage of the product.
Leadership to staff on the product world-wide so that all work is carried out with regards to Alexion standards and external regulations
Develop contacts with international and external opinion leaders, consultants, and collaborative groups
Provide leadership and direction to improvement projects/activities/initiatives
Identify & drive the development & utilization of leading-edge statistical methodology, skills, capabilities, tools, processes & best practice, in order to add value to drug development
Lead biostatistics resourcing to deliver projects and input on internal vs outsourcing delivery
Maintain understanding and awareness of, as well as investigate and implement, new methodologies, therapy area and development advances
May represent Alexion and biostatistics to Health Authorities and Reimbursement/Payer Organizations or high level internal governance committees for specific projects/indications
Competent program and project leadership
Work according to agreed functional and regional Safety, Health, and Environment (SHE) strategy by ensuring proper management of SHE risks, incidents, reporting, follow-up and improvements