Umoja Biopharma is seeking a Senior Director of Biometrics to lead the Biometrics function across the company's clinical development programs, ensuring scientific and data integrity standards are met for novel integrated immunotherapy platform development.
Requirements
- 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.
- Therapeutic area expertise in oncology, with particular interest in candidates with expertise in cell and gene therapy.
- Familiarity with CDISC standards (SDTM, ADaM).
Responsibilities
- 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).
Other
- Strong communication and leadership skills, with the ability to influence cross-functional teams.
- 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
- Demonstrated ability to thrive in a fast-paced, evolving biotech or pharma environment.
