Clinical Data Programmer in Edinburgh

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

Do you have expertise in Clinical Data Programming? Have you got the desire to improve health and lives? Charles River Laboratories are looking to recruit for a Clinical Data Programmer as part of their Clinical Support Services function on a full time, permanent basis. Working remotely (within the UK only), you’ll be a highly skilled team member, accountable for programmatically extracting, transforming, and reporting any complexity of test and production clinical datasets in an accurate and timely fashion in accordance with applicable requirements and guidelines.

This role would suit someone who has a strong understanding of how Clinical Trials are set up and conducted and how the data is collated and evaluated. Any industry-led experience of programming such data would be advantageous.

What you’ll be doing:

• Utilize code to produce production clinical datasets by working with team members in the operation of established systems and/or standardized code.
• Develop reusable code according to requirements, specifications, and following SOPs to produce clinical datasets for User Acceptance Testing (dummy and/or live data). Capable of integrating multiple, complex inputs into the desired output.
• Prepare as needed full SDTM and/or ADaM datasets.
• Review data and code to verify integrity and consistency for completeness, accuracy, and suitability, including data adherence to protocol, data coding integrity, reliability of collection, and interpretation.
• Lead in troubleshooting assigned generic code, application code or specific study work. Ensure clinical datasets are prepared in accordance with study documentation, such as a Data Transfer Agreement, and with applicable regulations.
• Maintain organized, complete, and up-to-date study documentation, testing, and quality control documents and programs in compliance with company standards and regulatory guidelines.
• Review Data Transfer Agreements and/or Specifications.
• Keep internal and external stakeholders informed of strategy, plans and changes as needed to provide quality products and services.
• Responsible for assigned study schedules and for coordinating internal and external resources.
• Support application development and study code standardization.
• Manage complex workload from assigned study projects with priority clients and expedited timelines.
• Mentor peers and junior staff in support of business needs and team development.
• Design, develop, implement, support, and administer validated and unvalidated systems that produce custom tables and graphs including statistical analyses, and systems that promote business intelligence across the organization.
• Research, review, and advise on new technology that may be used within the department. Draft and/or update relevant SOPs and other procedural documents.
• Able to function as team lead and support the Supervisor as needed with scheduling and other administrative activities.
• Perform all other related duties as assigned.

Skills and Experience:

• Bachelor’s Degree (B.S./B.A.); scientific discipline preferred. SAS certification may be considered in lieu of education requirement.
• Significant experience with SAS; in a regulated environment or clinical research organization experience preferred.
• Demonstrated experience in SAS is required; including SAS macros, arrays, SQL, SAS Graph, and knowledge with different output formats (e.g., .rtf, .xml, .xpt).
• Proficiency with a programming language other than SAS (e.g., .NET, VBA) a plus.
• Familiarity with the System Development Lifecycle (SDLC) a plus.
• Demonstrated excellent organizational skills.
• Basic familiarity with Microsoft Office Suite.
• Computer skills, commensurate with Essential Functions, including the ability to learn a validated system.
• Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts, sometimes on short notice.
• Ability to work under specific time constraints.

All applicants must have full and permanent Right to Work in the UK as we are unable to provide sponsorship for this role. The salary range for this role is £30,000 - £34,000/annum + bonus + benefits. Please note that the salary varies within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.