Statistical Programming Lead
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
- You will act independently as Global Programmer Lead (GPROGL) for an early stage or non-complex asset, supports the Astellas data transparency effort by programming statistical summaries for regulatory-mandated disclosure and represent Astellas on programming matters during inspections.
- In addition, you will be responsible for programming vendor oversight for assigned compounds and contributions to functional/departmental infrastructure projects.
- Under guidance, you will also support the generation of complex TLFs, act as GPROGL late phase or offer training/mentoring to other programmers.
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
- Hands-on programming experience within one or more statistical/data science programming languages (e.g., R, SAS). This includes writing code to manipulate data and analyze a wide array of data sources/types
- Understanding of pharmaceutical industry leading practices (e.g., regulatory framework, inspection process, HTA guidance, technologies, systems, etc.)
- 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.
- Understanding of common statistical and data quality systems and tools (e.g., Pinnacle 21, SETI, etc.)
Continue: Role and Responsibilities
- For clinical trials, post marketing or early phase support and for asset support:
- Is 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)),
- Is a key collaborator with statistics in ensuring that specifications are complete and statistical plans are executed efficiently with the right level of validation.
- Is the single point of contact for assigned studies, coordinates the activities of the programming team internally, and liaises with the lead programmer at the vendor (as applicable).
- Enforces Astellas, industry and regulatory standards in programmed deliverables (including CDISC standards for datasets and internal TLF standards) so that deliverables are ready to be used in regulatory submissions.
- Actively participates in the development and implementation of programming tools for Statistical Programming infrastructure projects.
- Leads Statistical programming activities related to the disclosure of Astellas clinical trial data to regulatory agencies and research-based sites.
- Is responsible to efficiently communicate, at regular intervals, to Global Programmer Lead (GPROGL) and/or line management on study/project/initiative status and resource issues.
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
Benefits
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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