Statistical Scientist Lead

At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their caregivers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

The primary purpose of the Associate Director is to act independently as Study Statistician / Medical Affairs Statistician (MA) / Exploratory Statistician / Regional Statistician Lead (RSTATL) or Lead Product Statistician (LPS) for complex/novel work in an established area (clinical/observational studies, MA tactic, Biomarker & PK/PD Analyses or local project). This position may also act as Global Statistical Lead (GSTATL) for an early or back up asset or as a Methodology expert validating the execution of complex techniques. Under the supervision of an experienced statistician, you will act as global statistical lead (GSTATL) for a late-phase or novel asset or represent Astellas on statistical matters related to clinical data, Biomarkers, PK/PD, PROs, or methodology at meetings with regulatory authorities, key opinion leaders, and HTAs.

At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.

Key Activities for this role:

• Provides best in class data science support to Astellas drug development programs and for studies within assigned projects, provides all required statistical support and deliverables by supervising another statistician, or as a member of study team.
• Ensures quality and consistency of key data science deliverables across studies.
• For early or noncomplex assets, independently provides strategic statistical input to the asset teams (for example, CDP, CMP, go/no go approach, OCs), including design of studies and analyses requiring advanced statistical methodologies.
• Executes biomarker and PK/PD strategies, leads large/complex studies or supports marketed products.
• Contributes to regulatory and payer dossiers and publications - provides statistical interpretation of the results.
• Ensures availability of biomarker, external data, CRF integrated database(s) where needed, and planning and conduct of integrated analyses to support development decisions, submissions or marketing needs.

Essential Knowledge & Experience:

• Substantial years of experience in applying statistical methods in biomedical research, Pharma, CRO, Academia, or Healthcare industry, or in providing statistical direction in these areas.
• Solid experience with pharmacokinetics (PK).
• Advanced and broad knowledge of statistical methods, along with the understanding of industry practices related to the statistical analysis of clinical and biomarker data.
• Knowledge and skills in SAS required, knowledge of R preferred.
• In-depth familiarity with processes and procedures in data management and programming.
• Experience working in an international environment.
• Good knowledge of medical literature, clinical, regulatory, and commercial landscape.
• Ability to understand, implement, and explain complex statistical methodology.

Education/Qualifications:

• PhD or M.S in Biostatistics, Statistics or related scientific field or equivalent.

This is a permanent role based in the United Kingdom. This position follows our hybrid working model. Role requires a blend of home and minimum once a quarter in our Addlestone office. Flexibility may be required in line with business need.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.