Director or Senior Director – Biostatistics
| Company | Kymera Therapeutics |
|---|---|
| Location | Belmont, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Master’s |
| Experience Level | Senior, Expert or higher |
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.
- 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.
Responsibilities
- Act as the lead statistician of a clinical program, leading statistical efforts and representing biometrics functions on program teams. Make strategic contributions to the clinical development plan.
- Serve as the biostatistical lead for 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.
Preferred Qualifications
- R or Python is advantageous.