Statistical Programming Lead

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 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:
We have an exciting opportunity for a Statistical Programming Lead to join our new hub Data Science team in the UK to work within our established Data Science/Statistical & RWD division on a global scale alongside over 200 team members internationally.
As a Statistical Programming Lead, you will be responsible for programming vendor oversight for assigned compounds and contributing to functional/departmental infrastructure projects.
You will also be assigned to the most complex tasks, offer training/mentoring to other programmers, and lead assigned Statistical Programming and Data Science strategic objectives and drive implementation of relevant functional objectives.
Key Activities for this role:
Is responsible for the production of high-quality, on-time statistical programming deliverables (such as datasets and tables/listings/figures (TLFs). Ensures that integrated programmed deliverables are ready to be used in regulatory submissions and follow Astellas, industry and regulatory standards.
Directly leads the internal programming team for insourced work; for outsourced work, the position liaises with the lead at the vendor.
Provides regular oversight of statistical programming work outsourced to Full-Service Providers (FSPs) and acts as a liaison between the FSP and Astellas.
Recognizes and addresses issues that may impact the validity or completeness of the deliverables
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).
Relevant experience as senior/principal lead programmer for a drug development program gained within the pharmaceutical or a related industry and exposure to working with vendors.
Substantial years of experience of relevant programming experience in the pharmaceutical industry and working with vendors
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.
Education/Qualifications: Bachelor’s or master’s in statistics, mathematics, or a related field.
Additional information: This 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.
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