Description
Statistical Programming Specialist:
About Astellas
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focusing 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.
Opportunity
As a Statistical Programmer, you will take ownership of programming tasks and play a key role in delivering high-quality programming for clinical and Medical Affairs studies. You'll work on complex and innovative projects within development programs, which include clinical/observational studies, PK/PD analysis, Biomarker research, and regional studies. You'll be responsible for global deliverables at both the study and submission levels, within one or more Primary Focus (PF) areas.
In this role, you'll also provide oversight of programming vendors for assigned compounds, ensuring deliverables meet the highest standards. You'll have the chance to contribute to the improvement of departmental and functional infrastructure, helping us build stronger programming practices across the organisation.
For complex tasks — spanning from individual late-phase clinical trials to global regulatory application submissions, HTA submissions, and post-marketing support — the role is focused on delivering excellence and innovation.
Hybrid Working
At Astellas we recognise the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimise the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.
Responsibilities And Accountabilities
* Producing high-quality, on-time statistical programming deliverables, including datasets and tables/listings/figures (TLFs), ensuring all outputs are fully compliant with Astellas, industry, and regulatory standards.
* Ensuring integrated programmed deliverables are submission-ready and meeting the expectations for global regulatory use.
* Overseeing the efficient use and management of programming vendors to maintain consistency, quality, and timeliness.
* Leading the internal programming team for insourced work, and collaborating with vendor leads for outsourced projects to ensure seamless communication and delivery.
* Providing regular oversight of statistical programming activities performed by Full-Service Providers (FSPs), and acting as the key liaison between Astellas and its external partners.
Personal Development / Collaboration
* Recognising and addressing issues that could impact the validity, accuracy, or completeness of deliverables.
* Contributing to cross-functional and indication-level improvement initiatives, such as writing SOPs, implementing innovative statistical software, standardising outputs, and maintaining adherence to indication-specific programming standards.
* Collaborating with peers to devise creative and efficient solutions for common programming challenges.
* Supporting the recruiting, training, developing, and retaining of talented statistical programming professionals.
* Engaging with external professional and industry organisations, building networks, and sharing knowledge to stay at the forefront of best practices in statistical programming.
Required Experience
* Demonstrating solid experience in statistical programming within the pharmaceutical industry, including extensive collaboration with external vendors.
* Bringing proven expertise as a lead programmer overseeing programming activities across drug development programs.
* Possessing strong capability in mentoring, guiding, and developing statistical programmers to enhance team performance and technical excellence.
Education
* Bachelor's or master's in statistics, mathematics, or equivalent
Working Environment
* The is a permanent full-time position based in the UK.
* This position follows our hybrid working model. Role requires a blend of home and minimum of 1 day a quarter in our Addlestone office. Flexibility may be required in line with business need. 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.
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