Join to apply for the Statistical Scientist Lead role at Astellas Pharma
2 weeks ago Be among the first 25 applicants
Join to apply for the Statistical Scientist Lead role at Astellas Pharma
Get AI-powered advice on this job and more exclusive features.
About Astellas
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
Description
Statistical Scientist Lead
About Astellas
At 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 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 Opportunity
As Statistical Scientist Lead, 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.
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 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.
Additional Information
* 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. Candidates must be located within a commutable distance of the office
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.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Research, Analyst, and Information Technology
* Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Astellas Pharma by 2x
Sign in to set job alerts for “Lead Scientist” roles.
Principal Scientist, Global Technical Development
London, England, United Kingdom 3 weeks ago
Principal Scientist, Analytical Development
London, England, United Kingdom 3 weeks ago
London, England, United Kingdom 4 days ago
London, England, United Kingdom 1 week ago
Trainee Healthcare Scientist - Echocardiography (ETP)
London, England, United Kingdom 3 days ago
Lead Clinical Scientist & MPE Research Lead - Radiation Protection
Northwood, England, United Kingdom 3 days ago
Senior Biomedical Scientist (Night Shift Supervisor) - Biochemistry
London, England, United Kingdom 2 weeks ago
London, England, United Kingdom 1 week ago
Development Scientist (Assay Development)
London, England, United Kingdom 1 week ago
London, England, United Kingdom 2 weeks ago
London, England, United Kingdom 22 hours ago
Assay Development Scientist (Formulation Science)
London, England, United Kingdom 2 months ago
Teddington, England, United Kingdom 21 hours ago
Senior Data Scientist - London - Hybrid Working
Greater London, England, United Kingdom 3 weeks ago
Senior Clinical Scientist (Radiation Physics)
London, England, United Kingdom 3 days ago
Senior Clinical Scientist (Magnetic Resonance Physics)
London, England, United Kingdom 3 days ago
London, England, United Kingdom 5 months ago
London, England, United Kingdom 1 week ago
Reading, England, United Kingdom 2 hours ago
SENIOR CLINICAL SCIENTIST AI FELLOWSHIP IN HEAD AND NECK RADIOTHERAPY
London, England, United Kingdom 1 week ago
Clinical Scientist (MRI Safety/MRSE Qualified)
London, England, United Kingdom 1 month ago
Senior Biomedical Scientist (Clinical Biochemistry)
London, England, United Kingdom 1 week ago
London, England, United Kingdom 5 days ago
Senior Biomedical Scientist-Blood Transfusion
London, England, United Kingdom 1 week ago
London, England, United Kingdom 1 month ago
London, England, United Kingdom 1 month ago
Material Scientist – Materials Discovery & Library Development (Early Career Scientist)
London Area, United Kingdom 33 minutes ago
High Wycombe, England, United Kingdom 2 weeks ago
Transformation and Compliance Operational Lead (Biochemistry)
London, England, United Kingdom 1 week ago
London, England, United Kingdom 1 month ago
London, England, United Kingdom 2 weeks ago
Hammersmith, England, United Kingdom 1 month ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr