Senior Director, Biometrics

Senior Director, BiometricsUmoja Biopharma is a game-changing biotech start-up 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 the principles of Diversity Equity and Inclusion and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front.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 SummaryThe Senior Director of Biometrics will lead the Biometrics function across the company's clinical development programs. This role is responsible for providing strategic, scientific, and operational leadership for the design, analysis, and interpretation of clinical trials. The Senior Director will collaborate closely with Clinical Development, Regulatory Affairs, Informatics, Data Management, Statistical Programming, and external partners to ensure the highest scientific and data integrity standards are met.RequirementsSpecific responsibilities include:Provide statistical leadership across all phases of clinical development, from first-in-human to post-marketing studies.Collaborate with cross-functional teams to design clinical studies, including endpoints, sample size, randomization, and statistical analysis plans.Author, review and approve statistical analysis plans (SAPs), tables, listings, and figures (TLFs), and clinical study reports (CSRs).Collaborate with data scientists in Informatics to enable incorporation of clinical trial data into cross-domain exploratory and correlative analyses.As our clinical programs progress, lead and mentor a team of biostatisticians; build and develop internal capabilities and oversee outsourcing partners and CROs.Author and contribute to policies and SOPs defining standard processes and practices for biostatistics and related work.Serve as the biostatistics representative in regulatory interactions, including authoring and reviewing statistical content in regulatory submissions (e.g., INDs, NDAs, BLAs).Ensure statistical methodologies comply with regulatory requirements and industry best practices.Participate in due diligence and support business development activities from a statistical standpoint.Provide strategic input to senior leadership on statistical implications of clinical development strategies.When needed, develop the Biometrics function within the organization, potentially including management and development of the Data Management and Statistical Programming functions.The successful candidate will have:PhD in Biostatistics, Statistics, or related field; MS with significant industry experience may be considered.10/12+ years of experience (respectively) in clinical trial statistics, including late-phase development; 5+ years in a leadership role.Extensive experience interacting with regulatory authorities and supporting submissions (FDA, EMA, etc.).Proven experience managing internal teams and external vendors.Deep understanding of GCP, ICH, and regulatory guidance on statistical principles.Strong communication and leadership skills, with the ability to influence cross-functional teams.Preferred Qualifications:Therapeutic area expertise in oncology, with particular interest in candidates with expertise in cell and gene therapy.Experience in adaptive design, Bayesian methods, or complex innovative trial designs.Familiarity with CDISC standards (SDTM, ADaM).Demonstrated ability to thrive in a fast-paced, evolving biotech or pharma environment.Physical Requirements:Ability to work onsite in our Seattle, WA office at least 2x/week.Ability to travel occasionally.Ability to sit for long periods of time.Salary Range: $248,200 - $306,600