Job Description

Statistical Programming Lead
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:
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 contributes 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.
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 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.

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
• 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.)

Education:

• Bachelor's or master's in statistics, mathematics, or related field; or equivalent.

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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Skills Required