15 Jul
Senior SAS Programmer (CDM Group - FTE)
California, Sancarlos , 94070 Sancarlos USA

Vacancy expired!

The Senior SAS Programmer provides technical and operational expertise to the project teams and contributes to ensuring, the data collected meets the requirements of the study objectives for the purpose of clinical study reports, publications, and regulatory submissions. This position will lead and coordinate functions for multiple assigned projects related to the planning, execution, collection, and cleaning of clinical data. S/he will work within the company’s SOPs, guidelines, and standards to ensure data integrity at all times. S/he is responsible for developing and maintaining new/existing programs to support Clinical Data Management activities to Iovance’s quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. This position will manage essential duties and responsibilities as independently as possible. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs for late-stage cancer patients. Specific Responsibilities:

  • Develop, validate, and maintain new/existing SAS, QlikView and Business Objects programs/reports to support Clinical Data Management activities
  • Program SAS macros to establish standards and reduce redundant programming
  • Develop scripts to automate SAS job executions to reduce manual interventions
  • Oversee vendors and provide guidance and expert knowledge as needed
  • Participate in EDC screen design review meetings, as necessary.
  • Complete work according to SOPs, Work Instructions, and project specific guidelines in accordance with Good Clinical Practice.
  • Creation and review of programming specifications.
  • Provide technical support as needed for additional study build functionality including, but not limited to, reporting, outputs, and data transfer plans.
  • Support test script development and performance of user acceptance testing, as necessary.
  • Perform all work in accordance regulations for use of computerized systems in clinical trial.
  • Support Clinical Data Managers and other study team members to address any programming issues that arise from time to time during the study conduct.
  • Support the validation of EDC and other supporting software as needed.
  • Manage and prioritize project deliverables and personal workload to meet deadlines while maintaining the highest standards of work.
  • Perform other duties as assigned.
Education and Qualifications:
  • At minimum bachelor’s degree in Computer Science or Life Sciences or equivalent education and relevant experience.
  • 5+ years of SAS Programming experience
  • 5+ years of Pharmaceutical/CRO industry experience
  • Thorough understanding of regulations related to systems and programs used to handle clinical trials data.
  • Thorough understanding of clinical data structures, relational database structures and data exchange with alternate data formats
  • Knowledge of QlikView/Business Objects/any BI tool programming
  • Knowledge of Windows PowerShell/any scripting tools
  • Knowledge of Structured Query Language (SQL)
  • Knowledge of RAVE EDC system
  • Knowledge of Clinical Data Management
  • Excellent oral and written communication skills
  • Demonstrate ability to work in a team environment and collaborate with peers
  • Demonstrate good organizational ability, communication, and interpersonal skills
  • Flexibility and agility to adapt to changing scope of work
  • Able to travel (10% - 15%) as needed
Physical Requirements:
  • Sit for an extended time in front of a computer

Vacancy expired!


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