Fortrea

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Job Overview:

Performs independent programming activities (using Medidata Rave Or SAS) on multiple projects concurrently with less or no support from Senior Programmers. Development and implementation of solutions to global technical service issues and concerns regarding EDC tools like Medidata RAVE or Oracle Inform or Data/Report programming or Visual Analytics tools like Spotfire or Tableau. Create CRF Annotations and programming specifications for datasets creation using transfer / guidelines / CDISC / Client Standards. Develop and maintain SAS programs for creation of datasets using specifications / guidelines. Develop programs to import external data and transform to SAS Dataset or Excel files for data review and reconciliation. Maintain study databases for assigned projects and perform SAS programming as assigned by Managers. Prioritize workload to meet specified completion dates.

Summary of Responsibilities:

• Performs independent programming activities on multiple projects concurrently with less or no support from Senior Programmers. Development and implementation of solutions to global technical service issues and concerns regarding EDC tools like Medidata RAVE or Oracle Inform or SAS programming or other Programming languages / tools.
• Read understand requirement documents/Specifications, database design/SAS programming, Reports design and conduct quality control processes including database review to meet client requirements.
• Program ad-hoc/scheduled reports using SAS/Python/Cognos/Business Objects – XI /R and other tools for data cleaning and reporting.
• Develop/Validate programming specifications for mapping of SDTM datasets.
• Produce Define XML/pdfs, annotated ECRFs and Reviewers Guide for submission deliverables.
• Develop visual analytics dashboard using tools like Spotfire/Tableau.
• Perform any post-production changes, publish checks, complex structure dynamics, Rave Safety Gateway, Balance (RTSM) mapping setting to the EDC database or enhancements to the programs like SAS edit checks, listings, Protocol Deviations, etc.
• Complete assigned work utilizing EDC tools or SAS or other proprietary software according to Fortrea sops, Work Instructions and Instructions, project, and project specific guidelines in accordance with Good Clinical Practices.
• Train and mentor, the team on EDC tools or SAS as required and have them ready to perform independent enough on day-to-day activities.
• Serve as Lead Statistical Programmer providing programming support for development and maintenance of SAS datasets as per CDISC / Client Standards.
• 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.
• Develop/Validate programming specifications for generation of SAS datasets as per Client/CDISC standards.
• Program edit checks/quality checks on source data and communicate data issues to data management.
• Perform quality check and ensure the work is delivered with quality and with knowledge of regulations pertaining to computerized systems to ensure compliance.
• Continuously learn and improve communication, technical and problem-solving skills.
• Interact with project team members in related discipline and provide solutions to the operational issues.
• Able to work independently on multiple sponsors and take initiative to accept new challenges in Clinical Programming Applications.
• Reconcile database build, project files, reports, listings, and other documents related to programming for accuracy, completeness of Data Management processes.
• Work in a timely manner in accordance with all the activities specified in the agreed study budget, under the supervision of Sr. Programmers.
• Perform other duties as assigned by Manager.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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If, as a result of a disability, you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application.