Biostatistics Study Lead — Clinical Programs

Kymera Therapeutics; Boston (MA); On-site; USD 160,000 - 275,000; Full time

Job summary

Kymera Therapeutics is seeking a Study/Program Lead Statistician to drive the statistical strategy across a clinical program. You will lead biometrics, shape the development plan, and oversee outsourced statistics functions to ensure robust, regulatory-ready analyses.

The role requires a strong background in clinical trial statistics, FDA/EMA guidelines, and collaboration with cross-functional teams to deliver high-quality results. Competitive compensation and comprehensive benefits are provided.

Qualifications

• Advanced degree in Statistics or related field with minimum 6 years of clinical trial experience in biotechnology or pharma.
• Extensive knowledge of statistical methods for clinical trials and familiarity with FDA, EMA, and ICH guidelines.
• Expertise in SAS; R or Python is advantageous; experience with EAST or nQuery.
• Strong communication to translate statistics to non-statisticians and collaborate cross-functionally.
• Ability to manage multiple priorities in a fast-paced environment and drive methodological rigor.

Responsibilities

• Act as the lead statistician of a clinical study or program, leading statistical efforts and representing biometrics functions on study/program teams.
• Contribute to regulatory submissions and inspections, ensuring compliance with global regulatory standards.
• Develop and review statistical analysis plans for individual studies and ISS/ISE; create and edit outputs shells.
• Provide statistical input during CRF design to align with objectives and oversee CROs.
• Author statistical sections of clinical study reports and support publications and presentations.
• Manage relationships with CROs to ensure high-quality outputs and study compliance.
• May manage direct reports and provide guidance and professional development.

Skills

Statistical methods

Communication

Cross-functional collaboration

Prioritization

Education

Advanced degree in Statistics

Tools

SAS

R

Python

EAST

nQuery

Job description

Kymera Therapeutics is seeking a Study/Program Lead Statistician to drive the statistical strategy across a clinical program. You will lead biometrics, shape the development plan, and oversee outsourced statistics functions to ensure robust, regulatory-ready analyses.

The role requires a strong background in clinical trial statistics, FDA/EMA guidelines, and collaboration with cross-functional teams to deliver high-quality results. Competitive compensation and comprehensive benefits are provided.