Vice President, Biometrics

Kriya Therapeutics•Remote, NC

3d•Remote

About The Position

Kriya is a biopharmaceutical company developing gene therapies for diseases with high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology. The Vice President, Biometrics leads the company’s biostatistics, statistical programming, and clinical data management functions. The role develops and executes statistical and data strategy for the clinical pipeline, safeguards the integrity and quality of data supporting regulatory submissions, and builds the teams and systems required to advance programs from early clinical studies through registration. As a member of the clinical development leadership team, the VP partners with Clinical, Regulatory, Translational, CMC, and Quality. The role applies expertise in rare and common disease trial design, novel endpoints, natural history data, and external controls to develop rigorous and efficient data packages. It is primarily desk-based in an office or home office setting, with extended sitting and computer use; occasional travel may be required.

Requirements

PhD in Biostatistics, Statistics, or a related quantitative field; an MS with exceptional experience may be considered.
12 or more years of biometrics experience in the biotechnology or pharmaceutical industry.
5 or more years leading biometrics teams or functions.
Track record leading or substantially contributing to biometrics for successful regulatory submissions (NDA/BLA/MAA) and approvals.
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 executive management.
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

Develop and execute the biometrics strategy, operating model, and multi-year roadmap in alignment with the clinical development plan; represent Biometrics to executive management and, alongside the CMO, to the Board as needed.
Provide statistical leadership across programs, including trial design, sample size, endpoint selection, adaptive and Bayesian methods, interim analyses, and statistical analysis plans.
Lead the use of natural history data, external controls, and real-world evidence in support of development and regulatory strategy.
Lead biometrics content and execution, in partnership with Regulatory, 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, tables, listings, and figures (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; help build a scalable organization as the company moves toward commercial readiness; manage functional budgets and resource planning.