Manager, Biostatistics

Biostatistics Manager, Data Science

About Astellas:

At Astellas we offer an inspiring place to work and a chance to make your mark in doing good for others.

Our expertise, science and technology make us a Life Sciences company, our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.

Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.

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.

Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.

We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best minds together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.

About this job:

Due to continued success and growth, we are building a team of Study Statisticians, Support Statisticians, Statisticians and Exploratory Statisticians and have multiple positions for a Biostatistics Manager.

You will be part of our Data Science Division (DS) and Statistical & Real-World Data Science (SRS) team who designs Astellas’ development programs to allow data-driven decision-making. You will contribute to the design and reporting of clinical trials/observational studies under the supervision of a more senior Statistician.

Using state-of-the-art methodology and the most innovative approach, SRS generates compelling evidence using clinical trials or real-world data (RWD) to ensure successful and timely regulatory approval, pricing, reimbursement, and patient access. You could also act as a Methodology Statistician, validating the execution of routine statistical techniques and identifying situations where novel techniques may be appropriate.

This is an exciting time to join Astellas as we gear up to expand our team in the UK. We are looking for diverse talents and self-motivated individuals who are eager to make a difference.

Key activities are noted below:

• Contributing 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.
• Collaborating 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.
• Responsible for the quality and timeliness of all statistical deliverables of the assigned tasks.
• Contributing to clinical study reports, other reports, or publications by providing statistical interpretation of the results.
• Performing statistical analyses in accordance with protocol, SAP, good statistical practice, and available regulatory guidelines.
• Authors / reviews: synopsis, protocol, statistical analysis plans (SAP), Case Report Forms (CRF), Data Validation Plans, tables listings and figure (TLF) specifications
• Partnering and communicating effectively with other Data Science (DS) functions; in particular, providing Statistical Programmers with study details, timelines, specifications, and efficacy analyses algorithms. Statisticians and Programmers communicate frequently and update each other on progress of individual deliverables.

Essential Knowledge & Experience:

• Educated to M.S level or higher (or equivalent) in Biostatistics, Statistics, or related scientific field.
• Experience in applying statistical methods in biomedical research, Pharma, CRO, Academia or Healthcare industry.
• Hands-on programming experience within SAS, including data manipulation and analysis of a wide array of data sources/types. In addition, working knowledge of R is preferred.
• Understanding of and experience with pharmaceutical datasets, statistical methodology, P,V and NIPASS from data identification landscaping, etc.
• Understanding of how to transform research objectives into study design, regulatory publications, and abstracts.
• Excellent communication and interpersonal skills.
• Identifies/implements new ideas and methodologies, learn new techniques, and adjust to new approaches quickly.
• Ability to work independently to achieve results with a high degree of accuracy and attention to detail.

Additional information:

• This position is part of Biostatistics, Medical Affairs (MA) statistics, regional Statistics, Methodology & Simulations, or Exploratory statistics in SRS and a member of a deliverable team.
• This position is an individual contributor role.
• The is a permanent full-time position based in the UK.
• We offer a hybrid working pattern, requiring one day per quarter in the office (Addlestone), blended with a collaborative video environment that supports working from home.

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.