Vice President, Biometrics

Kriya Therapeutics, Inc.; North Carolina; Hybrid; USD 250,000 - 400,000; Full time

Job summary

Kriya Therapeutics, Inc. is seeking a Vice President of Biometrics to lead all biometrics functions, including biostatistics, programming, and data management.

This executive will shape the statistical strategy for the clinical pipeline and ensure data integrity for regulatory submissions. The role partners with Clinical, Regulatory, Translational, CMC, and Quality to advance programs from early studies through registration, applying advanced trial design and external data approaches where

Responsibilities

• Strategy and leadership: Develop and execute the biometrics strategy, operating model, and multi-year roadmap in line with the clinical plan.
• Biostatistics: Provide statistical leadership for trial design, endpoints, adaptive methods, and analyses across programs; use natural history data and external controls.
• Regulatory interaction: Lead biometrics content for FDA/EMA interactions; ensure submission-ready datasets and SDTM/ADaM packages meet agency standards.
• Statistical programming and data standards: Oversee SDTM/ADaM development, TLFs, analysis, and reusable macros to support quality and speed.
• Long-term follow-up: Manage follow-up activities and data capture strategies across programs.

Job description

Vice President, Biometrics

Department: Clinical

Employment Type: Full Time

Location: Remote

Description

Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.

We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.

We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.”

Role Overview

The Vice President, Biometrics leads all biometrics functions at Kriya Therapeutics, including biostatistics, statistical programming, and clinical data management. This leader develops and executes the statistical and data strategy for the clinical pipeline, ensures the integrity and quality of data supporting regulatory submissions, and builds the team and systems needed to move programs from early clinical studies through registration. The role is a member of the clinical development leadership team and a trusted partner to Clinical, Regulatory, Translational, CMC, and Quality.

The VP will apply deep expertise in rare and common disease trial design, novel endpoints, and natural history and external control approaches to a modality where the data package must be both rigorous and efficient.

Key Responsibilities

• Strategy and leadership. Develop and execute the biometrics strategy, operating model, and multi-year roadmap in line with the clinical development plan. Serve on the clinical development leadership team and represent Biometrics to executive management and, alongside the CMO, to the Board as needed.
• Biostatistics. Provide statistical leadership for trial design, sample size, endpoint selection, adaptive and Bayesian methods, interim analyses, and statistical analysis plans across all programs. Lead use of natural history data, external controls, and real-world evidence in support of development and regulatory strategy
• Regulatory interaction. 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.
• Statistical programming and data standards. Oversee SDTM and ADaM development, TLFs, integrated summaries, and programming validation. Establish standards, metadata repositories, and reusable macros that support quality and speed.
• Long-term follow-up