Clinical Trial à United States

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Description Statistical ScientistAbout 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: You will contribute to the design, analysis, and reporting of clinical trials/observational studies under the supervision of a more senior Statistician. You will also act as a Methodology Statistician, independently validating the execution of routine common statistical techniques and identifying situations where novel techniques may be appropriate. You are expected to complete routine tasks with an appropriate level of independence and in accordance with the project direction and standards. For more complex tasks, the position works under the supervision of a more senior Statistician. 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:

Contributes to the efficient planning, execution and reporting of clinical or observational studies, post hoc, HTA, regional, PK-PD or Biomarkers analyses with an appropriate level of independence

Authors / reviews: synopsis, protocol, statistical analysis plans (SAP), Case Report Forms (CRF), Data Validation Plans, tables listings and figure (TLF) specifications

Performs statistical analyses in accordance with protocol, SAP, good statistical practice, and available regulatory guidelines.

Collaborates with other study team members (e.g. programmer, data manager, clinical study manager, study medical lead) influencing team members from all disciplines on statistical design, analysis and methodology topics

Develops expertise beyond statistics by researching medical literature, understands clinical, regulatory, and commercial landscape and builds an adequate network with academic, regulators and industry peers

Contributes to clinical study reports, other reports or publications by providing statistical interpretation of the results.

Essential Knowledge & Experience:

PHD with a few years or Master's in Biostatistics with substantial years’ experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry

Good knowledge and skills in R required, knowledge of SAS preferred.

Working experience on Oncology (therapeutic area) and clinical trials/studies.

Education/Qualifications:

PhD or Master's in Biostatistics, Statistics/related scientific field Marketing, or equivalent.

Additional information:

This is a permanent role based in 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. #LI-Addlestone#LI-Hybrid#LI-EN1