Senior Vice President, Biometrics

Kriya Therapeutics•Remote, NC

3d•Remote

About The Position

The Senior Vice President, Biometrics leads Kriya Therapeutics’ biometrics functions, including biostatistics, statistical programming, and clinical data management. The role sets statistical and data strategy across the clinical pipeline, ensures the integrity and quality of data supporting regulatory submissions, and builds the team and systems needed to advance programs from early clinical studies through registration. As a member of the clinical development leadership team, the SVP partners with Clinical, Regulatory, Translational, CMC, and Quality. The role applies expertise in rare and common disease trial design, novel endpoints, natural history, and external-control approaches to gene therapy development. The SVP defines and executes the biometrics vision, operating model, and multi-year roadmap; leads statistical strategy and regulatory interactions; oversees programming, data standards, and clinical data management; and manages vendors, quality, compliance, budgets, and resources. The leader also develops and scales a high-performing organization as the company progresses toward commercial readiness. The position is primarily desk-based in an office or home-office setting, may involve extended sitting and computer use, and may require occasional travel.

Requirements

PhD in Biostatistics, Statistics, or a related quantitative field; an MS with exceptional experience may be considered.
15 or more years of biometrics experience in the biotechnology or pharmaceutical industry, including 7 or more years leading biometrics organizations.
Deep knowledge of CDISC standards, ICH guidelines, FDA and EMA expectations, and statistical methodology for novel and adaptive designs.
Demonstrated experience with health authority interactions, DSMB support, and inspection readiness.
Technical proficiency with SAS, R, and statistical programming, including SDTM, ADaM, and TLFs, plus oversight of clinical data management and EDC.
Experience managing CRO and vendor relationships and building scalable systems and processes.
Strong executive presence and ability to communicate complex statistical concepts clearly to cross-functional leaders, regulators, and investors.
Strategic thinking that connects data and statistical strategy to program value.
Scientific rigor combined with pragmatism and speed.
Cross-functional collaboration and ability to influence without authority.
Talent development and ability to lead, build, and scale teams.
Accountability for quality, timelines, and budget.

Nice To Haves

Experience with cell and gene therapy, rare disease, or ophthalmology, cardiology, or neurology programs is strongly preferred.

Responsibilities

Define and execute the biometrics vision, operating model, and multi-year roadmap aligned with the clinical development plan; represent Biometrics to executive management and the Board as needed.
Provide statistical leadership for trial design, sample size, endpoint selection, adaptive and Bayesian methods, interim analyses, and statistical analysis plans across programs.
Lead the use of natural history data, external controls, and real-world evidence in support of development and regulatory strategy.
Lead biometrics content and strategy for FDA, EMA, and other health authority interactions, including pre-IND, End-of-Phase meetings, Scientific Advice, INDs, and BLAs/MAAs.
Ensure submission-ready datasets, ADaM/SDTM packages, and define files meet CDISC and agency standards.
Oversee SDTM and ADaM development, TLFs, integrated summaries, and programming validation; establish standards, metadata repositories, and reusable macros.
Partner with Clinical Safety and Clinical Operations on long-term follow-up data strategy for gene therapy programs, including DSMB and independent data monitoring committee support.
Select, govern, and manage CROs and technology vendors for biometrics services, with performance metrics, quality agreements, and budget accountability.
Ensure high-quality, inspection-ready data collection, cleaning, and database lock across internal and CRO-managed studies.
Oversee EDC selection and build, data review, external data integration, and risk-based quality management.
Ensure compliance with GCP, ICH, 21 CFR Part 11, and applicable data privacy requirements; maintain inspection readiness and lead biometrics participation in audits and inspections.
Lead, develop, and retain a high-performing team; build a scalable organization and manage functional budgets and resource planning.