Umoja Biopharma
Associate Director, Clinical and Statistical Programming
Seattle, Washington, United States · Director
Sponsorship not specified$185k-$229kDetected 85 days ago
GCPStatisticsSAPClinical TrialsFDA RegulatorySASLeadershipCommunicationCollaborationMentoringBiostatisticsRegulatory Affairs
About the role
- Review data management plans, data transfer plans, and test EDC deployment to ensure readiness for downstream programming.
- Mentor and provide technical oversight to statistical and data programmers and contractors.
- This role provides technical and operational leadership to ensure compliant, high-quality analysis datasets, tables, listings, and figures (TLFs) in accordance with CDISC standards and FDA guidance.
Responsibilities
- Lead and support statistical programming activities for regulatory submissions including INDs, NDAs, and/or BLAs.
- Collaborate closely with biostatisticians, study physicians, data management, clinical operations, and safety review teams to review data or programming issues and improve the overall quality of clinical trial data.
- Support internal and external audits, inspections, and regulatory inquiries related to statistical programming deliverables.
- This role will partner closely with Biostatistics, Clinical Data Management, Clinical Operations, and Regulatory Affairs to support submission readiness and successful regulatory interactions.
- We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals.
- We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.
Requirements
- A solid comprehension of statistical programming principles, advanced SAS programming expertise, extensive experience in the preparation of regulatory submission packages, and substantial knowledge of CDISC standards.
- A sound working knowledge of ICH, FDA, and GCP regulations and guidelines.
- Provide hands-on SAS programming support for key safety and efficacy analyses of clinical trials, as well as ad hoc exploratory and publication analyses as required.
Nice to have
- Prior experience with NDA/ BLA submission and interaction with regulatory agencies is highly desirable, as is leading early and late-phase clinical trials.
- Experience in immunology, hematology, or oncology clinical trials is preferred
- Experience with using R in clinical analysis
- Physical Requirements:
- Ability to sit for prolonged periods of time
Compensation
- $185,100 - $228,700
- Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral.
Benefits
- Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans.
- Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend.
- For a full breakdown of our benefits offerings, please see the Benefits section of our website.
- Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time.
Company info
- We are open to remote within the US for the right candidate.
- Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral.
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This listing is sourced directly from Umoja Biopharma's careers page and normalized into a canonical job model.