Remote Senior VP Biometrics & Data Strategy

Kriya Therapeutics, Inc.; North Carolina; Híbrido; USD 350.000 - 650.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Equity

401(k) with Company Match

Parental Leave

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Coverage

Descripción de la vacante

Kriya Therapeutics, Inc. seeks a Senior Vice President, Biometrics to lead biostatistics, programming, and data management across the clinical pipeline.

You will set the data strategy, ensure regulatory submission quality, and build a team and systems to move programs from early studies to registration. You will apply expertise in trial design, external controls, and modern statistical methods to deliver rigorous, efficient data packages for rare and common diseases.

Formación

• PhD in Biostatistics or related quantitative field; MS with exceptional experience may be considered.
• 15+ years biometrics experience in biotech/pharma, including 7+ years leading biometrics
• Proven track record leading biometrics for regulatory submissions (NDA/BLA/MAA) and approvals
• Deep knowledge of CDISC, ICH, FDA/EMA expectations; health authority interactions
• Expertise with SAS, R, SDTM/ADaM, and programming standards
• Experience managing CROs/vendors and scalable systems/processes
• Strong executive presence and cross-functional communication
• Strategic thinking connecting data strategy to program value
• Talent development and building scalable teams
• Accountability for quality, timelines, and budget

Responsabilidades

• Define biometrics vision, operating model, and multi-year roadmap; represent Biometrics to leadership and Board
• Provide statistical leadership for trial design, sample size, endpoints, adaptive methods, interim analyses
• Lead regulatory strategy for FDA/EMA; ensure submission-ready datasets and CDISC standards
• Oversee SDTM/ADaM development, TLFs, and metadata standards; reusable macros
• Partner on long-term follow-up and safety data for gene therapy programs
• Select, govern, and manage CROs/vendors with budget accountability
• Ensure high-quality, inspection-ready data; oversee EDC selection and data management
• Maintain GCP/ICH compliance and inspection readiness; support audits/inspections
• Lead, develop, and retain a high-performing biometrics organization; scale with company
• Collaborate cross-functionally to align data strategy with program value

Conocimientos

PhD in Biostatistics

15+ years biometrics

7+ years leadership

CDISC standards

SAS

R

CRO/vendor management

Executive communication

Strategic thinking

Cross-functional collaboration

Talent development

Quality and budget accountability

Educación

PhD in Biostatistics or related field

MS with exceptional experience considered

Herramientas

SAS

R

SDTM

ADaM

TLFs

EDC

Descripción del empleo

Kriya Therapeutics, Inc. seeks a Senior Vice President, Biometrics to lead biostatistics, programming, and data management across the clinical pipeline.

You will set the data strategy, ensure regulatory submission quality, and build a team and systems to move programs from early studies to registration. You will apply expertise in trial design, external controls, and modern statistical methods to deliver rigorous, efficient data packages for rare and common diseases.