Sr. Clinical Data Manager/SAS programmer

The Senior Clinical Data Manager is an individual contributor performing complex data management tasks independently. The Senior Clinical Data Manager plays a key role on multiple moderate to complex studies. This role will also need moderate to strong SAS programming skills.

Reporting Relationship:  Senior Director, Data Management

Responsibilities

  • Develops, or plans and oversees development of, edit check specifications, CRF Completion Guidelines or Data Entry Guidelines, Data Management Plan, Data Review Guidelines, SAE Reconciliation Plan, Cross-functional Data Review Plan, with input from cross-functional study team
  • Plans and oversees execution of User Acceptance Testing.
  • Defines Electronic Data Transfer Specifications
  • Ensures study compliance with SOPs and regulations and develops study-specific training for internal and external study team
  • Reviews clinical study protocols and provides input
  • Reviews vendor RFIs, RFPs, proposals, and contracts and provide input
  • Prepares and delivers presentations at internal and external meetings
  • Oversees activities of a CDM team on multiple studies, including internal staff and vendors
  • Evaluates and mitigates risks to timelines and quality
  • Provides input regarding project resource requirements
  • Responsible for all aspects of the CDM study deliverables
  • Provides SAS programming support to review and validate legacy SAS code that was developed for DM tasks such as complex/specialty data listings, extract programs,  SAS dataset to CSV file conversion, etc.
  • Develops complex data listings on an as needed basis

Qualifications

  • Prefer B.S. (or equivalent degree) in a scientific or allied health field.
  • 4-6 years of relevant work experience in the Biotech or Pharmaceutical Industry, or equivalent comparable background

Job Location: Cambridge, MA

Please send resumes to talentacquisition@bostonbiomedical.com