Position Summary:
The Statistical Programmer Contractor is responsible for developing, validating, and maintaining SAS programming deliverables to support clinical study analysis and reporting. This role collaborates closely with Biostatistics and other cross-functional team members to produce high-quality, compliant datasets, tables, listings, and figures while ensuring adherence to project timelines, SOPs, regulatory requirements, and CDISC standards.
Responsibilities:
- Program and validate tables, listings, figures, and derived datasets using SAS.
- Develop SDTM and ADaM specs, datasets, and supporting documentation.
- Prepare and review mapping specifications, annotated case report forms (aCRF), define, SDRG, ADRG and other files needed in the submission.
- Perform quality control and validation activities for all programming deliverables.
- Collaborate with study team members to identify, investigate, and resolve data and output issues.
- Review study documents and provide input to improve programming quality, efficiency, and consistency.
- Maintain complete, accurate, and audit-/inspection-ready programming documentation.
- Communicate project status, risks, issues, and timeline impacts clearly to stakeholders.
- Other as assigned.
Qualifications:
- Bachelor’s degree required; Master’s degree preferred in Statistics, Biostatistics, Mathematics, Computer Science, or a related field.
- Minimum of 10 years of relevant statistical programming experience within the pharmaceutical, biotechnology, or CRO industry.
- Phase 3 and regulatory submission experience preferred.
- Strong SAS programming skills, with experience developing SDTM, ADaM, tables, listings, and figures.
- Strong knowledge of clinical trial processes, regulatory requirements, and programming documentation.
- High attention to detail, with strong analytical, problem-solving, and communication skills.
- Ability to work independently and manage multiple priorities in a deadline-driven environment.
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.
Skills Required
- Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field
- At least 10 years of relevant statistical programming experience in the pharmaceutical, biotechnology, or CRO industry
- Strong SAS programming skills
- Experience developing SDTM and ADaM datasets, tables, listings, and figures
- Strong knowledge of clinical trial processes, regulatory requirements, and programming documentation
- High attention to detail, analytical and problem-solving skills, and strong communication skills
- Ability to work independently and manage multiple priorities in a deadline-driven environment
- Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field
- Phase 3 and regulatory submission experience
What We Do
ProKidney (Nasdaq: PROK), a pioneer in the treatment of CKD through innovations in cellular therapy, was founded in 2015 after a decade of research. ProKidney’s lead product candidate, REACT™ (Renal Autologous Cell Therapy), is a first-of-its-kind, patented disease-modifying autologous cellular therapy with the potential to not only slow and stabilize the progression of CKD, but in some cases potentially drive meaningful improvement in kidney function. Late-stage CKD, Stage 3b - 4, is a key target for REACT™ therapy. REACT™ has received Regenerative Medicine Advanced Therapy (RMAT) designation, as well as FDA and EMA guidance, supporting its ongoing Phase 3 clinical program, which launched in January 2022. For more information, visit www.prokidney.com.
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