APPROVED FOR REMOTE WORK

Program data review listings/reports and create different types of metric reports to various stake holders as needed using SAS. This role will report to Head of Data Management & Clinical Programming, diligently work with all study data managers and be very much involved in Clinical Data Reviews with cross-functional teams. Must have strong firsthand knowledge of Medidata Rave and clinical databases.

Job Duties and Responsibilities:

• Maintain, improvise current library of SAS programs and be able to develop new as per the demands of the cross-functional stakeholders
• Create SAS program specifications for Non-System Edit Checks based on CRF and non-CRF data
• Ability to independently develop innovative and complex SAS programs to support activities including development of various metric reports not limited to data listings and reports
• Participate in the development and review of data transfer specifications, processing of clinical data downloads and data transfers to/from service providers
• Knowledge of Medidata Rave Administration, Core Configuration settings, Cloud Admin. etc. and working with respective vendor CROs on databases
• Create Clinical Data Review Tools such as listings, study metrics, external data reconciliation Listings, SAE reconciliation automation, etc. for all studies based on study specific requirements
• Work with data managers to develop new or improve existing data review tools
• Coordinate with data managers regarding timelines and deliverables to ensure all SAS programs are working as expected
• Support initiatives for Data Management in implementation of visualization tools using Spotfire

Qualifications and Experience:

• Bachelor's degree in Life Science, Computer Science, or Mathematics with a minimum of 8 years of data management and SAS programming experience in the pharmaceutical industry. Depth and exposure to DM and programming related tasks considered in lieu of the minimum requirement
• Must have very strong SAS programming skills
• Base SAS certified and Medidata Rave Certified builder is a plus
• Conversant in best Clinical Data Management practices
• Knowledge and experience in clinical databases, electronic data capture systems, quality control processes and auditing procedures
• Familiarity with Medidata Rave custom reports using Meds Reporter tool is desirable.
• Familiarity with GCP, ICH and FDA requirements applicable to clinical data
• Knowledge of industry standards (CDISC, SDTM, CDASH)
• Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)
• Experience in regular interactions with Data Managers and clinical study teams
• Excellent teamwork, written and oral communication skills
• Strong critical thinking skills

FibroGen is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender identity/expression, creed, national origin/ancestry, age, alienage or citizenship, status, age, sex, sexual orientation, marital or domestic/civil partnership status, disability, veteran status, genetic information, or any other basis protected by law.FibroGen will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.

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Notice to Recruiters and Search Firms
FibroGen makes every effort to source and hire its staff through direct recruitment methods. Employment opportunities at FibroGen are managed by our internal human resources team. Please do not contact hiring managers or other FibroGen employees.

FibroGen does not accept unsolicited resumes from any source other than from the candidates themselves. FibroGen does not accept unsolicited communications from external recruiters. If there is a specific business need, a human resources team member will contact external recruiters directly.

An agency or independent recruiter must have a current, signed agreement and a work order for a specific position with FibroGen before presenting candidates and must be presented to human resources. Submission of unsolicited resumes without a signed agreement and an applicable work order will not create an obligation on the part of FibroGen to pay a fee of any kind.

Job Type: Full-time

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