Statistical Programmer

Statistical Programmer 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 Programmer, you will contribute to the statistical programming needs of several clinical studies or Medical Affairs studies within a development program; the work involves the programming of study including post hoc, HTA, regional, PK/PD, and Biomarker analyses or regional projects. In this role, you will be expected to understand when to seek Global Programming Led to ensure successful outcomes with respect to resource requirements or key strategic functional issues for a late phase or novel asset and represent Astellas on programming matters during inspections. Hybrid Working: At Astellas we recognize 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; optimizing the most productive work environment for you to succeed and deliver. Key Responsibilities: Identify and communicate project goals, timelines, and milestones. Identify project interdependencies and potential constraints. Assign roles and hold stakeholders accountable to meet project outcomes on time and within budget. Ability to read, analyze, and communicate large and small amounts of data effectively including teaching/explaining data-driven results to others. Applies experience that can span across statistical modelling, data mining, descriptive statistics, and other data analysis techniques. Essential Knowledge & Experience: 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. Hands-on programming experience within one or more statistical/data science programming languages (e.g., R, SAS, or Python). This includes writing code to manipulate data and analyze a wide array of data sources/types. 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. Knowledge of study documents such as Protocol, SAP, TLF specs, and data specification. Preferred Knowledge & Experience: Oncology experience is desirable. Education/Qualifications: Bachelor’s or master’s in statistics, mathematics, or equivalent. Additional Information: This is a permanent, full-time position. This 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.