Job Description

General Information

Job Advert Title
Statistical Programming Lead (Associate director)
Location
United Kingdom
Function/Business Area
Research
Employment Class
Permanent

Description

Statistical Programming Lead (Associate director)
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need.  Learn more at Astellas.com
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Location and Working Environment
HYBRID - This position is hybrid and will require you to be onsite one day per quarter in Surrey, Addlestone office.
Astellas’ Responsible Flexibility Guidelines Statement- At Astellas we recognize 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 optimize 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.
Purpose & Scope

• 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 represent Astellas on programming matters during inspections. The position is assigned to the most complex tasks, offers training/mentoring to other programmers and leads assigned

Role and Responsibilities

• 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.

Continuing: Role and 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.

Required Qualifications

• Bachelor’s or master’s in statistics, mathematics, or related field

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors

• Impact
• Innovation
• Integrity
• One Astellas
• Accountability
• Courage
• Sense of Urgency
• Outcome Focus

BenefitsCareers | Astellas
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, 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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