Member of Technical Staff – Biostatistics

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and assess AI agent systems aimed at automating statistical analysis and clinical development processes.

• Collaborate directly with pharmaceutical and biotech companies as a biostatistics subject matter expert deployed in the field.

• Establish benchmarks to evaluate agent performance in trial design, Statistical Analysis Plan (SAP) development, and high-quality statistical deliverables for submissions.

• Enhance agent functionality in partnership with the internal AI engineering team.

• Grasp partners’ statistical methodologies, study design principles, and regulatory standards.

• Advance the capability of LLM agents to perform coherent statistical analysis and trial design tasks in scientific settings and client data infrastructures.

• Create benchmarks, acceptance criteria, and identify failure modes for intricate biostatistical tasks.

• Collaborate with client biostatisticians and clinical development leaders on AI applications for statistical and regulatory output.

• Act as the statistical authority on AI-generated results, assessing their accuracy and adherence to regulatory standards.

• Recognize failure modes and ascertain issues that require additional scrutiny.

• Team up with GTM and account executives to outline project scopes, establish success metrics, and assist in pre-sales technical evaluations.

• Forge trusted relationships with customer biostatisticians and research leaders.

⛳️ Requirements

• A minimum of 5 years of experience in biostatistical applications within the biotech or pharmaceutical sectors (either as a sponsor or in a Contract Research Organization).

• A graduate degree in Statistics, Biostatistics, or a related field.

• Demonstrated proficiency in developing SAPs, calculating sample sizes, and designing early-phase (I/II) clinical trials.

• Expertise in R and/or SAS is required.

• Preferred experience in therapeutic areas such as oncology, immuno-oncology, immunology, cardiovascular, neurology, or hepatology (MASH).

• Strong understanding of ICH and FDA regulatory requirements.

• Direct experience with Clinical Study Reports (CSRs), Investigational New Drug (IND) submissions, and CDISC-compliant datasets (SDTM/ADaM).

• Previous experience in an industry setting or client-facing role, outside of academia.

• Willingness to travel domestically 20–40% of the time.

• Knowledge of Python and/or TypeScript/JavaScript is advantageous.

• Proficiency in statistical programming and validation, with the ability to quality check or independently reproduce analyses when necessary.

🏝️ Benefits

• Competitive salary and equity options.

• Comprehensive healthcare coverage; 100% of premiums are covered for you and your dependents.

• Annual stipend for new parents.

• Fertility assistance provided through Carrot.

• Mental health resources available through Rula.

• 12 weeks of paid parental leave for maternity, paternity, and adoption purposes.

• Yearly employer-funded stipend for pet care.

• Commuter benefits for transit and parking using pre-tax dollars.

• 401(k) matching contributions from the company.

• A quarterly health and wellness benefit of $300.

• Daily lunch provided in the office.

• Dinner supplied for late working hours.

• Regular team off-sites and company events.