Clinical Data Programmer, Repository Systems

Clinical Data Programmer, Repository Systems

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focusing 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.

About this job:

As we gear up to expand our team in the UK, we are looking to recruit Clinical DataRepository Systems Programmersat various levels, to join our Data Management Systems Programming team.

You will be responsible for end-to-end activities for programming and configuring Astellas’ Clinical DataRepository Systems inclusive of system setup, data validation, reports and analytics programming.

This is a unique opportunity to be part of our global data management team that collaborates in managing best practices and standards to maintain, enhance, improve, and innovate on efficient processes for Clinical Data systems programming.

We are looking for individuals with excellent verbal and written communications skills, with the ability to work and influence individuals across multiple discipline in an international environment.

Key activities are noted below:

• Managing (create, update, support) Clinical Data repository system setup (elluminate) of studies using system and study specific configurations, templates, and standards. This includes data mappings, reports programming, analytics programming, study setup, system configurations and applicable documentation (e.g., technical specifications, approval forms).
• Participating in Astellas end-to-end process to perform programming and setup activities such as data analysis, analysis, design, quality control, peer review, unit testing, user acceptance testing support, data setup, document authoring and reviews.
• Ensuring all related programming activities are complete per Astellas quality documents, standards, templates, and best practices.
• Improving technical processes to enhance efficiencies and leverage innovative solutions.
• Providing technical solutions to end users and stakeholders to support their challenges, understand the current state and requirements, and provides well-informed and innovative alternatives and solutions.

Essential Knowledge & Experience:

• Educated to degree level or higher (equivalent) in Computer Science, Informatics, or life science discipline; demonstrated previous experience in pharma or CRO industry in an informatics or programming role.
• Strong cross-functional understanding of processes of data management, clinical programming, biostatistics, and clinical operations, with high level of expertise expected in the DM systems discipline. Demonstrated experience in leading system selection and implementation projects.
• Strong computer skills, including database software management, reporting tools, medical coding tools or similar programmes.
• Solid knowledge of various programming methodologies and end to end system life cycle processes (e.g., Lean/Agile Methodology, Waterfall Methodology, SDLC).
• Strong understanding of different types of data sources and data integrity principles in clinical trials.
• Expert level understanding of data integrity principles and other associated industry, clinical and regulatory level best practices and requirements (e.g., GxP, GDPR).
• Advanced-level experience with T-SQL or PL-SQL programming.
• Experience with eClinical Solutions elluminate clinical system is preferred (or other similar systems).

Additional information:

• The is a permanent full-time position based in the UK.
• We offer a hybrid working pattern, requiring one day per quarter in the office (Addlestone), blended with a collaborative video environment that supports working from home.

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.