Senior Manager or Associate Director or Director of Biostatistics
About the job
- An advanced degree in Statistics or a related field and at least 6 years of clinical trial experience in a biotechnology or pharmaceutical company.
- Extensive knowledge of statistical methods for clinical trials and deep familiarity with FDA, EMA, and ICH guidelines.
- Expertise in SAS is required.
- Strong communication skills for effective collaboration with cross-functional teams, including the ability to communicate statistical concepts to non-statisticians, influence stakeholders, and ensure adoption of robust statistical methods.
- Ability to manage multiple priorities in a fast-paced environment.
- Strong analytical and problem-solving abilities.
- Act as the lead statistician for a clinical study or program, lead statistical efforts, represent biometrics functions on study or program teams, and make strategic contributions to the clinical development plan.
- Contribute to regulatory submissions and inspections, ensuring compliance with global regulatory standards.
- Contribute to clinical protocol development 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 and efficacy (ISS/ISE), and create and edit statistical output shells.
- Provide statistical input during case report form (CRF) design to align with study objectives and analysis requirements; oversee and quality-control results from statistical programmers or contract research organizations (CROs).
- Contribute statistical sections to clinical study reports and interpret study results; support 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, providing guidance and professional development.
- Experience with R or Python.
- Experience with trial design software such as EAST or nQuery.
- A strong interest in innovation in biostatistics and continuous process improvement.
- A positive attitude and collaborative spirit.
About the company
Kymera Therapeutics develops therapies that remove disease-causing proteins using targeted protein degradation. The company’s Pegasus Platform helps identify which proteins to degrade and then uses molecules that recruit the cell’s waste machinery to break down those proteins, aiming to treat cancers and immune diseases. This approach can create multiple drug candidates across different diseases. Kymera’s products are advanced through collaborations, most notably with Sanofi, which supports research, licensing, and milestone-based payments. Unlike traditional drugs that inhibit a protein’s function, Kymera’s strategy eliminates the protein itself, potentially offering new treatment options for patients. The company’s goal is to deliver new, effective medicines by degrading harmful proteins, expanding options in the biopharmaceutical market and addressing unmet medical needs.
Company Size
201-500
Company Stage
IPO
Headquarters
Watertown, Massachusetts
Founded
2016
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Simplify's Take
What believers are saying
- Kymera finished BROADEN2 enrollment six months early, accelerating top-line KT-621 data to year-end 2026.
- Gilead exercised KT-200 in April 2026, delivering a $45 million milestone and 2027 IND plans.
- Sanofi’s KT-485 Phase 1 started in 2026, adding validation and non-dilutive revenue.
What critics are saying
- KT-621 Phase 2b data by year-end 2026 can still disappoint after strong Phase 1b signals.
- KT-579’s Q4 2026 readout risks failure, leaving Kymera dependent on one clinical asset.
- RBC downgraded Kymera in July 2026, while heavy insider selling pressures the stock.
What makes Kymera Therapeutics unique
- Pegasus platform produces oral degraders against previously inaccessible targets in immunology and oncology.
- KT-621 is the first oral STAT6 degrader, entering Phase 2b across atopic dermatitis and asthma.
- Gilead and Sanofi partnerships validate Kymera’s chemistry, biology, and translational execution.
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Benefits
- Hybrid Work Options