Biostatistics SME — AI-Driven Clinical Trials (Forward-Deployed)

Edison Scientific; Boston, New York, San Francisco (MA, NY, CA); Hybride; USD 180 000 - 240 000; Plein temps

Avantages offerts par ce poste

Full healthcare coverage

Parental leave benefits

Wellness stipend

Commuter benefits

401(k) matching

Equity

Résumé du poste

Edison Scientific is seeking a Forward-Deployed Biostatistics Subject Matter Expert to build and evaluate AI agent systems for automated statistical analysis in clinical development workflows. You will work embedded with pharma/biotech partners to ensure regulator-ready outputs and benchmark agent performance on trial design tasks.

Ideal candidates have 5+ years in biostatistics, a PhD in statistics/biostatistics, and strong expertise in SAPs, sample size determinations, and regulatory standards

Qualifications

• 5+ years in biostatistical applications within biotech or pharma.
• Graduate degree (Ph.D. preferred) in statistics/biostatistics or related field.
• Experience crafting SAPs, sample size calculations, and early-phase trial design.
• Proficiency with regulatory standards (ICH/FDA) and SDTM/ADaM datasets.

Responsabilités

• Improve LLM agent performance for long, coherent statistical analyses in real-world data.
• Design benchmarks to evaluate agent accuracy, acceptance criteria, and failure modes.
• Collaborate with biostatisticians and clinicians to apply AI to regulatory deliverables.
• Serve as statistical authority on AI outputs, ensuring regulator-ready quality.
• Engage with GTM and accounts to define scope and support evaluations.
• Build credibility with customers as a statistical AI expert.

Connaissances

Biostatistics

Clinical trial design

Regulatory knowledge

Client-facing

Statistical methodology

Independent work

Formation

PhD in Statistics/Biostatistics or related

Outils

R

SAS

Python

Description du poste

About Us

Edison Scientific builds and deploys AI scientist agents to accelerate science and the development of new medicines. We are an ambitious team run by scientists and engineers from leading institutions across biology, physics, chemistry, and AI.

About the Role

As a Forward-Deployed Biostatistician, you will build and evaluate AI agent systems to automate statistical analysis and clinical development workflows. You'll be embedded directly with some of the world's leading pharma and biotech organizations, and will be responsible for ensuring Edison's AI agents deliver statistically sound, regulator-ready outputs. You'll work with our partners to create benchmarks that measure agent performance on complex tasks across trial design, SAP development, and submission-quality statistical deliverables, then work with our internal AI engineering team to improve agent performance on those tasks. You'll need to deeply understand our partners' statistical methodology, their study design conventions, and their regulatory bar, then determine where our platform can drive the most meaningful impact.

Key Responsibilities

• Improving the ability of LLM agents to execute long, coherent statistical analysis and trial design tasks within real-world scientific environments and customer data infrastructures.

• Designing benchmarks to evaluate LLM agent performance, acceptance criteria, and failure modes on complex biostatistical tasks (e.g., SAP development, sample size determination, endpoint analysis).

• Partnering directly with biostatisticians and clinical development leaders at client organizations to apply AI agents to statistical and regulatory deliverables.

• Serving as the statistical authority on AI-generated outputs, evaluating accuracy and regulatory soundness, identifying failure modes, and determining what warrants further investigation.

• Partner with GTM and account executives to scope engagements, define success metrics, and support pre-sales technical evaluation.

• Build trusted relationships with biostatisticians and research leaders at customers, earning credibility as both a statistical peer and a knowledgeable AI practitioner.

Required Qualifications

• 5+ years of experience in biostatistical applications within biotech or pharma (sponsor or CRO).

• Graduate degree (Ph.D. preferred) in Statistics, Biostatistics, or a related discipline.

• Proven expertise in crafting SAPs, determining sample sizes, and designing early-phase (I/II) clinical trials.

• Proficiency in R and/or SAS (both preferred).

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

• Deep familiarity with ICH and FDA regulatory standards, including direct experience with CSRs, IND filings, and CDISC-compliant datasets (SDTM/ADaM).

• Prior experience in an industry or client-facing context, outside of academia.

• Ability to travel domestically 20-40% of the time.

Preferred Qualifications

• Proficiency in Python and/or TypeScript/JavaScript.

• You enjoy quickly iterating on ideas through rapid prototyping.

• You operate with high independence, and like to execute complex tasks to completion in a high-stakes environment.

• You thrive when working on a diversity of projects in sprint-based formats, and have high comfort with uncertainty.

• You are proficient in statistical programming and validation, and could QC or independently reproduce an analysis if necessary.

Salary

$180k - $250k • Offers equity

Why join us?

We're a fast-moving, mission-driven culture where smart people do their best work and actually enjoy doing it. We also offer full-time employees the following:

• Competitive salary and equity

• Full healthcare coverage; we pay 100% of premiums for you and your dependents

• Support for growing families, including a yearly new parent stipend and fertility coverage through Carrot

• Mental health support through Rula, our in-network therapist and psychiatrist network with fast availability

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

• Pet care support with a yearly employer-funded stipend for your animal companions

• Commuter benefits so you can pay for transit and parking with pre-tax dollars

• 401(k) company matching

• $300 health and wellness benefit quarterly

• Lunch is on us every day you're in the office, and dinner is on us when you're working late

• Regular team off-sites and company events

Edison Scientific is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic under applicable law.