About Astellas:
At Astellas we 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 Life Sciences 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 minds together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
The Opportunity:
Would you like to join an organisation at the forefront of healthcare innovation, transforming cutting-edge science into VALUE for patients? Bring your unique skills, experience, perspectives, and ideas to Astellas.
As Statistical Programming Lead (Associate Director), 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).
This includes global accountability of all programmed deliverables at the study and submission level within assigned programs in one or more Primary Focus (PF) areas. In addition, the position is responsible for programming vendor oversight for assigned compounds and contributes to functional/departmental infrastructure projects.
You will act independently as Global Programmer Lead (GPROGL) for a late stage / complex asset and represents Astellas on programming matters during inspections. The position is assigned to the most complex tasks, offers training/mentoring to other programmers and leads assigned.
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.
Key Responsibilities:
- For complex tasks, the span of which ranges from individual late phase clinical trials to world-wide regulatory application submissions, HTA submissions and post marketing support
- 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.
- Is accountable for the efficient use and oversight of programming vendors.
- 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 acting as a liaison between the FSP and Astellas.
- Recognizes and addresses issues which 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).
- Works with peers in devising innovative solutions to common problems which arise in the efficient execution of statistical programs.
- Contributes to the recruitment, training, professional development, and retention of statistical programming personnel.
Essential Knowledge & Experience:
- Substantial years of experience of relevant programming experience in the pharmaceutical industry and working with vendors
- Strong experience as a lead programmer for a drug development program
- Demonstrable experience in mentoring/leading statistical programmers
- Strong Oncology therapeutic area experience.
Education:
- Bachelor’s or master’s in statistics, mathematics, or related field
Additional information:
- The is a permanent full-time position.
- This position is based in the UK.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local 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.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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