Job Overview:
Lead the development and implementation of solutions to global technical services issues and concerns regarding EDC tools like Medidata RAVE or Oracle Inform or Data/Report programming or Visual Analytics tools like Spotfire or Tableau. Develop/validate Custom/Complex SAS / SDTM datasets and efficiently handle external data and reconciliations. Perform any postproduction changes to the EDC database or enhancements to the SAS programs like SAS edit checks, listings, Protocol Deviations, SAS Datasets etc., Conduct Peer Review/Quality control of study design for assigned projects.
Summary of Responsibilities:
- Lead the development and implementation of Clinical solutions to global technical services issues and concerns regarding EDC tools or SAS programming.
- Lead the development of visual analytics dashboard using tools like Spotfire/Tableau.
- Complete assigned work utilizing Medidata Rave or Oracle Inform or other proprietary software according to Fortrea SOPs, Work Instructions, and project specific guidelines in accordance with Good Clinical Practices.
- Perform any post-production changes to the EDC database or enhancements to the SAS programs like SAS edit checks, listings, Protocol Deviations, etc.,
- With assistance, meet with Data Manager on assigned projects to discuss contractual obligations and timelines.
- Act as Subject Matter Expert (SME) and be point of contact for any technical services, issues related to EDC tools or SAS programming.
- Serve as Lead Statistical Programmer providing programming support for development and maintenance of SDTM/Client standards datasets.
- Develop/validate Custom/Complex SDTM domains and efficiently handle external data and data reconciliations.
- Develop and implement SDTM automation/standardization and best programming practices across projects to enhance quality and productivity.
- Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
- Exhibit good imparting, analytical skills along with testing, troubleshooting, error fixing, and documentation skills.
- Participate in the ongoing review of the processes used to ensure adaptation of best practices.
- Conduct Peer Review/Quality control of study design for assigned projects.
- Able to work independently and take initiative to accept new challenges in Clinical Programming Applications, also participate in the validation of new or updates to software.
- Maintain awareness of new developments in EDC products which may be applied to improve the efficient use of these systems.
- Resource forecasting and allocate activities to the team members on the project.
- Proactively identify trends, generate reports/metrics, or demonstrate programming processes to sponsors/auditors (if required), assist with the design of ECRFs and other study documents.
- And all other duties as needed or assigned
Qualifications (Minimum Required):
- University / college degree (life sciences, health sciences, information technology or related subjects preferred).
- Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree.
- Fluent in English, both written and verbal.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required):
- 5 to 8 years of relevant work experience to include data management and database support or SAS Programming or Spotfire or Tableau development.
- Good problem-solving skills and a proactive approach.
- Good oral and written communication skills.
- Basic knowledge of clinical trial process and data management, biometrics, and systems applications to support operations preferred.
- Demonstrated ability to work in a team environment.
- Demonstrated ability to work independently under supervision.
- Proven interpersonal skills.
Physical Demands/Work Environment:
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