United Kingdom Job Openings

Astellas Pharma Europe

Statistical Programming Lead

Addlestone

FULL TIME

September 5, 2024

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 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:
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.
As a senior level programming lead, you will 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).
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).
Lead the internal programming team for insourced work; for outsourced work, the position liaises with the lead at the vendor.
Contribute 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:

Previous experience as principal/Associate director 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.
Knowledge of the data science lifecycle and process flow (e.g., ETL, data quality, statistical data analysis, machine learning, data randomization.
Experience in clinical data standards (CDISC), TLFs, and submission guidelines.
Ability to read, analyze, 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.

Education/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.
Job Types: Full-time, Permanent
Work Location: Hybrid remote in Addlestone, KT15 2NX

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