Associate Director or Director, Biostatistics

Kymera Therapeutics•Watertown, MA

3d•$160,000 - $275,000

About The Position

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. The company values being PIONEER: courageous, resilient and rigorous in their mission to improve patients’ lives through revolutionary degrader medicines. They COLLABORATE: valuing trust + transparency, with shared goals, data-driven decisions and genuine camaraderie. They BELONG: recognizing differences, inviting curiosity and inclusivity, so that people are valued, seen, and heard.

Requirements

Advanced degree in Statistics or related field
Minimum 6 years of clinical trial experience in a biotechnology or pharma company
Extensive knowledge of statistical methods for clinical trials
Deep familiarity with FDA, EMA, and ICH guidelines
Expertise in SAS required
Strong communication skills necessary for effective collaboration with cross-functional teams
Ability to communicate statistics to non-statisticians effectively; influence and ensure adoption of robust statistical methods
Exceptional ability to manage multiple priorities in a fast-paced environment
Strong analytical and problem-solving abilities
Positive attitude and a collaborative spirit

Nice To Haves

R or Python is advantageous
Experience with trial design software such as EAST or nQuery
A strong passion for innovation in Biostatistics and continuous improvement in processes

Responsibilities

Act as the lead statistician of a clinical study or program, leading statistical efforts and representing biometrics functions on study/program teams.
Make strategic contributions to the clinical development plan.
Contribute to regulatory submissions and inspections, ensuring compliance with global regulatory standards.
Contribute to the development of clinical protocols by authoring the statistical methods section and reviewing other sections for statistical accuracy.
Develop and review statistical analysis plans for individual studies and integrated summaries of safety/efficacy (ISS/ISE).
Create and edit statistical outputs shells.
Provide statistical input during CRF design to ensure alignment with study objectives and analyze requirements.
Oversee and quality control results from statistical programmers or CROs.
Contribute to clinical study reports by authoring statistical sections and interpreting study results.
Support the preparation of scientific publications and presentations.
Manage relationships with CROs to ensure high-quality statistical outputs and compliance with study requirements.
May manage direct reports, as needed, providing guidance and professional development.