United States onlyResponsibilities:
- Uses SAS to develop programming code to generate summary tables, data listings, graphs, and derived datasets, SDTM and ADaM, as specified in the statistical analysis plan and programming specifications.
- Creates SDTM and ADaM mapping specifications and, if required, annotation of case report forms (CRFs) to CDISC standards.
- Works to ensure that outputs meet quality standards and project requirements.
- Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
- Keeps project team members informed of programming progress and issues requiring their attention.
- Follows applicable SOPs, WIs, and relevant regulatory guidelines.
- Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
- Adapts to timeline or priority changes.
- Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.
- Performs other tasks as assigned.
Qualifications:
- 10+ years' experience in Pharma, Biotech, or CRO.
- Preference for Phase 3 and BLA/NDA submission experience.
- Master’s degree preferred (in Statistics, Computer Science, or a related science discipline).
- Strong team player.
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
