Vice President, Biometrics

Dispatch Bio•San Francisco, CA

9d•$280,000 - $355,000

About The Position

Dispatch is seeking a Vice President, Biometrics to establish and lead its Biometrics function as the company enters clinical development. Reporting to the Chief Medical Officer, this role will be an early member of the Development team and join shortly after the start of the first clinical study. The position will define the company’s biometrics strategy, standards, processes and vendor model across biostatistics, statistical programming and clinical data management. It is a hands-on builder role, initially without a large team, with responsibility for performing and reviewing work while scaling the function thoughtfully as the pipeline grows. The Vice President will provide statistical leadership for development strategy, including study design, dose selection, interpretation of emerging data and program decisions. The role will partner with Regulatory Affairs, Clinical Operations, Clinical Development, Program and Portfolio Management, Product Team Leads, Translational Science, Research and Technical Operations. It will also select and oversee CROs, functional service providers, data management vendors and statistical consultants, and support engagement with regulators, safety and data monitoring committees, investigators, investors and partners. The role includes leading statistical contributions to the ongoing first-in-human study and regulatory interactions, overseeing clinical data management and vendor performance, integrating translational and exploratory data, and ensuring statistically sound external data communications. The successful candidate will help prepare the function for a growing, multi-program and multi-region clinical portfolio.

Requirements

Ph.D. in Statistics, Biostatistics or a related quantitative field.
At least 15 years of clinical development statistics experience in the biopharmaceutical industry, with progressive leadership responsibility, including leading a biostatistics or biometrics function or serving as lead statistician across multiple programs.
Substantial hands-on oncology experience, including design and analysis of early-phase oncology studies and familiarity with oncology endpoints and response criteria such as RECIST and time-to-event endpoints.
Demonstrated expertise in innovative early-phase designs, including dose-escalation and dose-expansion approaches.
Direct experience leading statistical contributions to FDA interactions and regulatory submissions, such as INDs and end-of-phase meetings, and contribution to at least one BLA/NDA/MAA.
Strong working knowledge of ICH guidelines, including E9/E9(R1), GCP, CDISC standards and relevant FDA guidance.
Track record selecting and overseeing CROs and functional service providers in an outsourced operating model.
Hands-on proficiency in SAS and/or R and willingness to personally perform and quality-check analyses.
Comfort operating as a leader with a small team, initially with no team, and a strong desire to build.
Collaborative approach and ability to influence peers and leaders without relying on hierarchy.
Excellent organizational, problem-solving and time-management skills, with sound judgment in managing competing priorities.
Positive attitude, dedicated work ethic and flexibility for a fast-paced, entrepreneurial environment where processes are still being built.
Strong verbal and written communication skills, including ability to translate complex technical concepts for clinical, scientific, executive and external audiences.
Comfort giving and inviting candid feedback and flagging risks early.

Nice To Haves

Experience with cell therapy (such as CAR T) or gene therapy programs, including analysis of cellular kinetics and immune-related safety events such as CRS and ICANS.
Oncology experience, especially solid tumors and gastrointestinal cancers.
Experience supporting expedited regulatory pathways, including Breakthrough Therapy designation and accelerated approval based on single-arm studies.
Experience with Bayesian methods, external control arms or real-world evidence in a regulatory context.
Prior experience as the first or founding biometrics leader at an early-stage biotech.
Experience supporting ex-US clinical studies.
Experience supporting business development diligence, financing or IPO-related data activities.

Responsibilities

Build the biometrics function, including its strategy, operating model, SOPs, data standards, templates and analysis infrastructure.
Serve as hands-on lead statistician for the ongoing first-in-human study; author and review statistical protocol sections, statistical analysis plans, TLF specifications and data review plans, and perform or quality-check key analyses.
Provide statistical leadership for early-phase study design, including dose-escalation and dose-expansion strategies, dose-finding methods, two-stage and single-arm designs, efficacy and futility boundaries, and dose optimization.
Interpret emerging safety and efficacy data to support safety review committees, interim analyses and program go/no-go decisions.
Partner with Clinical Development and Program and Portfolio Management on clinical development plans and target product profiles, including sample size, probability-of-success and scenario analyses.
Lead statistical content for regulatory interactions and submissions in partnership with the VP Regulatory Affairs, and plan for integrated analyses and BLA readiness.
Oversee clinical data management with Clinical Operations, including EDC build, data quality and cleaning, data review, database lock, data integrity and inspection readiness.
Select, contract and manage CROs and biometrics vendors, ensuring quality, timelines and budget accountability.
Collaborate with Translational Science to incorporate biomarker, pharmacokinetic/cellular kinetic and exploratory data into analyses.
Evaluate innovative approaches such as AI and machine learning, external controls and real-world data where they add value.
Ensure accurate and appropriate statistical framing of external data communications, including abstracts, presentations, publications and data shared with partners and investors.
Scale the function as the company develops a multi-program, multi-region clinical portfolio, hiring and developing team members as business needs grow.