CDISC Consultant

Ockham is a global provider of resources to the Biotechnology and Pharmaceutical Industry. We work with companies involved with clinical trials and other market approval processes to help them deliver their products on time and on budget. One of our clients in Any City is looking for a CDISC Consultant and a Senior CDISC Consultant. This is a contract position. Position will be telecommute.

Key Responsibilities:

The Senior CDISC Consultant will work in the CDISC Consultancy Group (CCG). The CCG is primarily responsible for supporting the compliant and consistent adoption of the CDISC Study Data Tabulation Model (SDTM). This position will be based at South San Francisco site but can work remotely in the US. The role will provide SDTM consultancy support for new and ongoing studies and involve close collaboration with SDF Implementers, Biostatistical Programmers, Global Librarians, and Data Stewardship Representatives.

Responsibilities include (but are not limited to):
  • Participate in SDF implementation and study team meetings to provide expert advice on SDTM mapping
  • Resolve study level mapping issues in a timely manner and escalate global issues for CCG leadership discussion
  • Host CCG team meetings and prepare meeting agenda and minutes
  • Lead other CDISC Consultants on CRF annotation and SDTM Controlled Terminology Management
  • Contribute to team and process documentation
  • Serve as Therapeutic Area Global Librarian to maintain SDTM Controlled Terminology
  • Perform SDTM audits and conformance checks to ensure SDTM compliance
  • Assist study teams in defining and developing submission documentation including define.xml and reviewers guide
  • Work with project manager and other CDSIC Consultants to ensure timely deliverables for study milestones
  • Support standard process improvement initiatives
Basic Qualifications:
  • BA/BS or higher degree in Computer Science, Statistics, Mathematics, Life Sciences, other related scientific subject
  • 7 years of pharmaceutical/biotech industry experience for Senior
  • 5 years of pharmaceutical/biotech industry experience for Consultant
  • 5 years of SDTM consulting experience conformance assurance, standardization, harmonization, liaising, problem-solving for Senior
  • 3 years of SDTM consulting experience conformance assurance, standardization, harmonization, liaising, problem-solving for Consultant
  • In-depth knowledge on SDTM standard official training from CDISC preferred
  • Active member of CDISC Submission Data Standards (SDS) team highly preferred
  • Thorough understanding and experience on data quality and compliance checks DAT, WebSDM, OpenCDISC
  • Prior regulatory submission experience with SDTM data and define.xml
  • Project management experience prioritizing, resourcing, following timeline, issue tracking
  • Prior leadership or management position
  • Effective oral and written communication
  • Good documentation practice
  • Willingness and ability to learn and follow standard processes and procedures in team environment
  • Ability to work proactively and independently
Posted: 2012-03-29
Location: Global
Environment: Home-Based
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