Kymera is seeking a Lead Statistician to spearhead statistical efforts for a clinical program and contribute to the development of medicines that address critical health problems.
Requirements
- Advanced degree in Statistics or related field with minimum 6 years of clinical trial experience in a biotechnology or pharma company.
- Extensive knowledge of statistical methods for clinical trials and deep familiarity with FDA, EMA, and ICH guidelines.
- Expertise in SAS required; R or Python is advantageous.
- Experience with trial design software such as EAST or nQuery.
Responsibilities
- Act as the lead statistician of a clinical program, leading statistical efforts and representing biometrics functions on program teams.
- 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).
- 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.
Other
- 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.
- A strong passion for innovation in Biostatistics and continuous improvement in processes.
- Strong analytical and problem-solving abilities.
- Positive attitude and a collaborative spirit.
- Advanced degree in Statistics or related field with minimum 6 years of clinical trial experience in a biotechnology or pharma company.
