Umoja BioPharma

Title: Associate Director, Clinical and Statistical Programming Location: Seattle United States Job Description: Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. 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. Umoja Biopharma - Your Body. Your Hope. Your Cure. POSITION SUMMARY The Associate Director, Statistical Programming will be responsible for strategic planning, executing and quality checking of data programming and statistical analysis deliverables to support clinical trial conduction and prepare submission readiness package. 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. This role will operate as an individual contributor and is responsible for enhancing the statistical programming infrastructure of the Biometric department, building and leading a highly efficient data and matrixed statistical programming team (contractors, vendors, CROs, FTEs) over time. This role will partner closely with Biostatistics, Clinical Data Management, Clinical Operations, and Regulatory Affairs to support submission readiness and successful regulatory interactions. This role will ideally be based out of our Seattle, WA location and work onsite at least 2 days/week. We are open to remote within the US for the right candidate. CORE ACCOUNTABILITIES Specific responsibilities include: - Lead statistical programming activities for clinical trials and ensure the timely delivery of high-quality outputs throughout the full study life cycle. - Review clinical trial protocols, SAP, CRF designs, and EDC deployments, and provide input for EDC edit checks to enhance clinical trial data quality. - Guide and review outputs from CROs, which may encompass submission datasets, programs, and outputs to ensure the submission package (SDTM and ADaM specifications, SDTM and ADaM programs and datasets, Tables, Listings, and Figures (TLFs) outputs, define.xml, and reviewer guides, etc.) adheres to regulatory requirements and is compliant with CDISC standards. - Lead and support statistical programming activities for regulatory submissions including INDs, NDAs, and/or BLAs. - Review data management plans, data transfer plans, and test EDC deployment to ensure readiness for downstream programming. - 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. - Mentor and provide technical oversight to statistical and data programmers and contractors. - 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. - Assist the department head in building the infrastructure of the biometrics department, which may include creating macros and programs, TLF shells, departmental SOPs, and best practices for statistical programming and data traceability. The successful candidate will have: - MS in biostatistics, statistics, computer science, or a closely related field, coupled with extensive quantitative analysis methodologies and statistical programming proficiency with a minimum of 10 years of experience in pharmaceutical companies or CROs is required. - At least 5 years of demonstrated leadership experience in projects and managing, mentoring, and developing teams. - 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. - Exceptional attention to detail and a strong risk-mitigation mindset, a self-driven learner to continuous learning and updating programming skills and therapeutic area (TA) knowledge. - Excellent verbal, written, and interpersonal communication skills are mandatory for clear and efficient communication and collaboration with cross-functional teams, which may include clinical operations, data management, study physicians, statisticians, and medical writers. - A sound working knowledge of ICH, FDA, and GCP regulations and guidelines. Preferred Qualifications: - 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 - Ability to read, interpret, and review detailed technical documents, datasets, tables, listings, figures, and on‑screen material - This role will ideally be based out of our Seattle, WA office and will be onsite 2 days/week - If this role is remote, the ability to travel up to 20% as needed Salary Range: $185,100 - $228,700 Benefits Offerings Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend.

Directly review and contribute to data listings, data exports, and interim analysis datasets in partnership with Biostatistics and Statistical Programming.

Senior Medical Director Seattle, Washington, United States Umoja Biopharma – Your Body. Your Hope. Your Cure.  POSITION SUMMARY The Medical Director will serve as a clinical leader, providing medical and scientific expertise to support the development of our in vivo CAR-T therapy programs. This individual will play a critical role in clinical strategy, study design, execution, and regulatory interactions while partnering cross-functionally with R&D, Clinical Operations, Regulatory, and Program Leadership teams. The ideal candidate will bring deep experience in cell & gene therapy and a strong track record in oncology or rheumatology clinical development. We will consider candidates at either the Director or Senior Director level based on candidate's qualifications and experiences. CORE ACCOUNTABILITIES Specific responsibilities include:   - Provide medical leadership and clinical oversight for ongoing and planned in vivo CAR-T therapy programs. - Contribute to the clinical development strategy, including indication selection, trial design, and endpoints. - Serve as medical monitor for clinical studies, ensuring patient safety, data integrity, and compliance with GCP and regulatory requirements. - Lead preparation of clinical protocols, investigator brochures, clinical sections of regulatory filings (IND, CTA, BLA), and other medical documents. - Partner with Clinical Operations on trial execution, including site and investigator engagement, medical monitoring, and data review. - Engage with global regulatory agencies to support program advancement. - Provide scientific and clinical expertise to business development, investor relations, and partnership discussions as needed. - Collaborate closely with translational medicine, preclinical, and regulatory teams to align clinical strategy with scientific discoveries. - Stay current on emerging trends, competitors, and regulatory guidance in cell & gene therapy and oncology. - Work with external program partners collaboratively and effectively to deliver on contractual obligations while moving toward corporate goals and priorities.  The successful candidate will have: - Director Level: MD, MD/PhD, or equivalent medical degree. Board certification in Oncology, Hematology, or related specialty strongly preferred. 2-5 years of clinical development experience, including at least 2 years in the biotechnology or pharmaceutical industry. - Senior Director Level: MD, MD/PhD, or equivalent medical degree. Board certification in Oncology, Hematology, or related specialty strongly preferred. Minimum of 5 years of clinical development experience, including at least 4 years in the biotechnology or pharmaceutical industry. - Demonstrated expertise in cell & gene therapy, ideally with CAR-T or T-cell engaging modalities; experience in in vivo gene delivery a plus. - Direct experience in oncology clinical trial design, execution, and medical monitoring. - Strong knowledge of global regulatory requirements for early- and late-stage development of gene and cell therapies. - Proven ability to interact with investigators, KOLs, and regulatory authorities. - Excellent communication, leadership, and cross-functional collaboration skills. - Passion for innovation and commitment to advancing transformative therapies for patients. Physical Requirements:   - Ability to travel at least 6x per year to site initiation visits, domestic and international conferences, ad boards, etc - Ability to work onsite at least 2 days/week Director Salary Range: $250,000 - $313,000 Senior Director Salary Range: $270,000 - $333,000 Benefits Offerings Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend.

• Provide technical regulatory leadership and oversight for ongoing and planned in vivo CAR-T therapy programs • Responsible for the development of the CMC regulatory strategy for submissions including DMFs, IND, NDA/BLA and CTD regulatory filings • Lead technical modules and sections of global regulatory filings (IND/CTA/BLA/MAA submissions) • Interact with regulatory agencies and represent Regulatory CMC at HA meetings • Provide phase-appropriate strategic guidance/input related to current regulatory requirements for clinical trial applications and marketing applications • Coordinate, manage, and lead all CMC regulatory projects including management of budget, timelines, and submission planning • Ensure compliance with all CMC regulatory reporting requirements, including annual and periodic reports • Independently manage and prioritize Phase 1 IND through late-stage projects • Identify, communicate, and propose resolutions to routine and complex issues • Provide regulatory advice and guidance in the context of available scientific data • Collaborate closely with global regulatory lead, translational medicine, preclinical, clinical, and technical teams