Statistical Programming Lead
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
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 you are empowered and supported with hybrid working options where you can work where you feel most comfortable and productive.
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.
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.
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