Qualifications You are: Bachelor's degree OR certification. Minimum of 5 years of clinical SAS programming experience in the pharmaceutical industry. Working knowledge of CDISC SDTM mapping, specifications, conversion, domains, datasets, eCRF, eCRT. Experience with Package/define.xml development and SDTM data transfer operations on clinical studies. Understanding of regulatory More ❯
Reading, Oxfordshire, United Kingdom Hybrid / WFH Options
ICON
facing capacity (project leadership track only). Advanced/expert-level of project leadership/technical track, respectively, working knowledge of data structures (e.g., CDISC SDTM, ADaM), software development lifecycle and their implementation. Strong working knowledge of the types of risks associated with a study and the impact on key More ❯
at study or project level. Ensure alignment with the TA level data strategy as defined by the TA Data Strategy Director. Competent in relevant CDISC or other recognized industry standards and how these impact the programming team. Ensure consistency of program level standards. Provide accelerated feedback to assure well-written More ❯
non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Excellent knowledge of CDISC SDTM and ADaM implementation guidelines working independently in this area; producing, reviewing and updating complex dataset specifications (including efficacy); creating and debugging complex macros; reviewing … trial issues, design, and implementation Experience of regulatory submissions and associated industry guidance Familiarity with GCP and regulatory requirements Knowledge of SDTM and ADaM CDISCstandards APPLY NOW With the world's eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric More ❯
lead statistical programming projects, ensuring high-quality, on-time deliverables. This includes developing and validating SDTM and ADaM datasets, performing QC reviews, and ensuring CDISC compliance. You’ll resolve Pinnacle 21 validation issues, review TLFs for consistency, and contribute to regulatory submissions. You'll also create define.xml files, develop and … least 6 years’ experience in clinical trial statistical programming. Excellent knowledge of SAS essential with R advantageous. Good working knowledge of data structures e.g. CDISC, SDTM, ADaM, Comprehension of clinicaldatastandards (CDISC), TLFs, and submission guidelines. What in it for you: The opportunity to be involved in a growing More ❯
submission activities; producing and validating datasets and outputs to excellent quality while adhering to deliverable timelines. The ideal candidate will have excellent knowledge of CDISC SDTM and ADaM implementation guidelines, working independently in this area; producing, reviewing, and updating complex dataset specifications (including efficacy); creating and debugging complex macros; reviewing … trial issues, design, and implementation. Experience with regulatory submissions and associated industry guidance. Familiarity with GCP and regulatory requirements. Knowledge of SDTM and ADaM CDISC standards. Apply Now With the world's focus on clinical trial data, this is a fantastic time to join an award-winning, specialized biometric CRO More ❯
Skills Required Knowledge of Python, TypeScript, and relevant healthcare standards such as FHIR and CDISC. Especially with protocols and standards related to clinicaldata in motion and at rest. Responsibilities Utilize Entity Framework (ORM). Manage database migrations and work More ❯
outcome You have line management experience and have the ability to foster a collaborative and high-performance environment Bonus: You have experience working with CDISCstandards such as SDTM You have high agency and a bias for action You are passionate and curious about our mission; changing how the healthcare … by capturing and prioritising new requirements for upcoming trials Data leadership Advise others across the company on the use of datastandards such as CDISC SDTM, ADaM, SAS Mentors more junior members of your team What you'll focus on Make an impact across all areas of our business and More ❯