About Astellas:
At Astellas we can 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 pharma 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 brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
The Opportunity:
As a senior-level programmer, the primary purpose of the position, is to act independently and lead programming work for clinical studies or Medical Affairs studies, Exploratory/Regional work supporting complex/novel work within a development program (clinical/observational studies, MA tactic, PK/PD and Biomarker analyses or regional project).
As a Statistical Programming Lead, you will be accountable for all programmed deliverables at the study and submission level within assigned programs in one or more Primary Focus (PF) areas and responsible for programming vendor oversight for assigned compounds and contributing to functional/departmental infrastructure projects.
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:
- Responsible for the high-quality, on-time development and execution of statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets SDTM/ADAMs, tables, listings, figures (TLF)).
- Directly leads the internal programming team for insourced work; for outsourced work, the position liaises with the lead at the vendor.
- Contributes to cross-functional or indication level improvement initiatives (i.e., write SOP - implement novel statistical software - standard output generation - creation of, maintenance and adherence to indication specific standards).
Essential Knowledge & Experience:
- Relevant experience as principal-level lead programmer for a drug development program gained within the pharmaceutical or a related industry and exposure to working with vendors.
- SAS and preferably one or more statistical/data science programming languages such as R (training can be provided) or Python.
- An understanding of the data science lifecycle and process flow (e.g., ETL, data quality, statistical data analysis, machine learning, data randomization.
- Responsible for the high-quality, on-time development and execution of statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets SDTM/ADAMs, tables, listings, figures (TLF)),
- Comprehension of clinical data standards (CDISC), TLFs, and submission guidelines
- The ability to read, analyse, and communicate large and small amounts of data efficiently including teaching/explaining data-driven results to others.
Preferred Knowledge & Experience:
- Diverse Therapeutic Area experience would be desirable.
Educations/Qualifications:
- Bachelor’s or master’s in statistics, mathematics, or equivalent.
Additional information:
- This is a permanent, full-time position.
- Position is based in the United Kingdom.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our Addlestone office. Flexibility may be required in line with business needs. 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.