Clinical Programmer

A world-leading CRO is looking to hire a home-based Clinical Programmer on a permanent basis.

Dedicated to a global pharmaceutical company, you will work closely with Data Managers and Clinical Data Standards teams, your main responsibilities will include:

• Providing expertise, delivery and oversight of clinical programming deliverables from study set-up to submission-ready tabulation packages.
• Providing specifications for data models to be used for quality review and for final data model (SDTM); design mapping algorithms for non-standard conversions.
• Ensuring quality review of datasets (e.g. Pinnacle 21 compliance checking); ensuring datasets are available for stakeholder use (medical review, central monitoring, adaptive designs) and compliant for database lock.
• Program, or oversee Programming of, quality review checks and reports for use by Data Managers and other team members.
• Develop and maintain working knowledge and expertise in programming languages utilized in clinical programming (SAS, SQL)
• Creation of submission-ready SDTM packages for FDA or other regulatory authorities
• Acquiring and maintaining working knowledge in data collection tools such as Medidata Rave, LSAF, Pinnacle 21
• Working to CDISC standards such as SDTM, CDASH, Controlled Terminology and define.xml.

The successful candidate will have the following skillset:

• Technically capable, a strong communicator, highly organized and possess first class project management skills
• Bachelors Degree or higher/equivalent in Computer Science, Data Science, Data Engineering, Mathematics or another relevant Scientific field.
• Clinical Programming experience and experience working on a clinical trial
• Expert knowledge of SAS Programming, Define.xml, SDTM aCRF, cSDRGs
• Expert knowledge of data structures

For additional information and an informal discussion on this role, please apply now with an updated CV.