​SDTM Clinical Programmers

Location Europe
Discipline: Biometrics
Job type: Permanent
Salary: £Salary: €60,000 - €70,000 Per annum
Contact name: Geoff King

Contact email: geoff.king@rbwconsulting.com
Contact phone: 01293584300
Job ref: GK21644
Published: about 1 month ago
Expiry date: 12 June 2021

Location: Home based - Germany, Belgium, Netherlands, Eire

Geoff King at RBW Consulting is looking to recruit multiple Statistical Programmer IIs to work for a global CRO recently announced as one of the top places to work by the international publication Forbes. This highly respected CRO pride themselves in their collaborative work culture and social impact spanning over 80 countries worldwide and invite you to become part of this exciting period of growth for the company.

As part of a brand-new team of SDTM Programmers you will be working for the embedded function of a well-known pharmaceutical company while able to be fully home based. This is a fantastic opportunity to join, develop and progress your career in a really exciting new venture for both companies.

Salaries are dependent on experience and location ranging from €60,000 - €70,000 + additional financial incentives and career paths range from line management to subject matter expert and will be tailored specifically to you.

Main duties & responsibilities:

  • 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.

Key requirements:

  • Bachelors Degree or higher/equivalent in Computer Science or equivalent

  • 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

A comprehensive job description for your level is available upon request.

To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on +44 (0) 1293 584 300 and send your CV through to geoff.king@rbwconsulting.com or use the apply button on this page.

Salary: €60,000 - €70,000 Per annum