Statistical Scientist
About Astellas:
Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing 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 care-givers, 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 Opportunity:
As a member of cross-functional teams, 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 or novel work in an established area, including clinical/observational studies, MA tactics, Biomarker & PK/PD analyses, or local projects. This position may also serve as Global Statistical Lead (GSTATL) for an early or backup asset or act as a Methodology Expert, validating the execution of complex techniques.
The position is expected to complete these tasks with minimal supervision from the GSTATL, LPS, or Primary Focus Statistics Lead (PFSL). Under the supervision of an experienced statistician, the individual can act as a 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. Additionally, the position may be involved in researching innovative solutions and providing training to other statisticians.
Hybrid Working:
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:
- 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 non complex asset, 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. You will present summary data and analyses to key stakeholders in a compelling and clear manner.
- Ensures availability of biomarkers, external data, CRF integrated database(s) where needed, and planning and conduct of integrated analyses to support development decisions, submissions or marketing needs.
- May participate in due diligence activities, review data, and provide guidance to the company, with responsibility for implementing, explaining, and validating complex statistical methodologies.
- Personal development / Collaboration and recognizes and addresses issues which may impact the statistical integrity of the development program or for which novel statistical methodology may add value
- Contributes to cross-functional or indication level improvement initiatives (i.e write SOP - select, validate and implement statistical software - standard output generation - creation of, maintenance and adherence to indication specific standards - selection and qualification/audits of vendors)
- Contributes to the recruitment, training, professional development and retention of statistical personnel. A member of external industry or professional organizations, developing relations with leading academic institutions, advising internally on innovative Statistical methods or checking their correct implementation.
Essential Knowledge & Experience:
- Extensive experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry or in providing statistical direction in these areas
- Advanced and broad knowledge of statistical methods, along with 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 and 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.
Additional Information:
- This is a permanent, full-time position
- This position is based in London
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 days per quarter in our London office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
- At Astellas, we are proud to be an equal opportunity employer.
We celebrate diversity and are committed to creating an inclusive environment for all employees. 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.
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