Director Biostatistics

The Opportunity

insitro is using machine learning to yield new, clinically actionable insights into critical unmet needs for patients. We aim to "go fast and improve things" across the entire drug development process from platform to pipeline to patients and back again.

The Director Biostatistics is an opportunity to directly improve patients' lives by leading clinical trial biostatistics across four areas, each informed by machine learning: neurology/ neurodegeneration, metabolism, oncology, and innovative companion diagnostics. We are devoted to the effort to make clinical trials more helpful for patients and for drug developers. We believe that by focusing on what's best for patients, we can do what's best for drug development at the same time.

You will be responsible for developing and executing on our biostatistics strategy, directly impacting overall success of our clinical programs. You will implement biostatistical strategies and analysis plans to support the development of multiple therapeutics and diagnostics in interventional clinical trials from FIP through POC. You will also be at the forefront of implementing modern and emerging statistical approaches to bring new treatments faster and better to patients with unmet need.

The role can be either onsite (3 days per week) in our South San Francisco office or hybrid (~1 week per month) in our office. Additional travel may be needed to relevant medical and translational science conferences and health authorities.

Responsibilities

• Clinical trial design - dose escalation, sample size, randomization, endpoints, data collection, verification, analysis, reporting, and dissemination
• Clinical trial execution - statistical input safety review, dose escalation, and efficacy evaluation, oversight of data collection and analysis, support for study timelines, quality and regulatory standards, data integrity, and statistical oversight to CRO/FSPs.
• Clinical study documentation - create statistical components of all clinical study-related documents
• Cross-functional - establish and maintain biostatistics standards, processes, and best practices, including statistics SOPs, GCP, best practices, software tools/utilities, datafile structure, and database design.
• Statistical programming - lead and manage statistical programming activities, provide hands-on programming support for clinical studies, oversee programming work by the CROs/FSPs, ensure programming accuracy, consistency, and compliance with regulatory standards.
• Management - serve as biostatistics lead for the initial clinical-stage asset(s); over time, help build and manage a focused, effective team of biostatisticians to match our growing pipeline.
• Collaboration - collaborate effectively with cross-functional teams on programming strategies including specifications, analysis datasets, and analysis outputs.
• Ad hoc - biostatistics support to scientific teams, including experimental design, power calculations etc.

About You

• Ph.D. or equivalent in statistics, biostatistics, or a related field.
• 5+ years of experience in statistical programming in the pharmaceutical or biotechnology industry, including experience in clinical trial data analysis and reporting.
• Experience in at least one of our key therapeutic areas (metabolic disease, neurology/neurodegeneration, oncology) is preferred.
• Proficiency in frequentist and Bayesian biostatistical approaches and models for adaptive design endpoint evaluation.
• Experience with frequentist and Bayesian dose escalation designs.
• Experience with multi-centre trials.
• Experience with real world and observational data.
• Strong proficiency in statistical programming languages, such as SAS or R.
• Experience managing and working with CRO/FSPs. Strong working knowledge of CDISC SDTM and ADaM Implementation Guidelines.
• Ability to work independently as well as lead statistics teams.
• Strong communication and collaboration skills, with the ability to work effectively with cross-functional teams and external partners.
• Experience in regulatory submissions, integrated analyses (ISE/ISS), or similar activities.
• Experience working in a fast-paced and dynamic environment, with the ability to adapt to changing priorities and timelines.
• Experience/familiarity with statistical genetics and target discovery is a plus.

Compensation & Benefits at insitro

Our target starting salary for successful US-based applicants for this role is $230,000 - $290,000. To determine starting pay, we consider multiple job-related factors including a candidate's skills, education and experience, market demand, business needs, and internal parity. We may also adjust this range in the future based on market data.

This role is eligible for participation in our Annual Performance Bonus Plan (based on company targets by role level and annual company performance) and our Equity Incentive Plan, subject to the terms of those plans and associated policies.

In addition, insitro also provides our employees:

• 401(k) plan with employer matching for contributions
• Excellent medical, dental, and vision coverage (insitro pays 100% of premiums for employees on our base plans), as well as mental health and well-being support
• Open, flexible vacation policy
• Paid parental leave
• Quarterly budget for books and online courses for self-development
• Support to occasionally attend professional conferences that are meaningful to your career growth and development
• New hire stipend for home office setup
• Monthly cell phone & internet stipend
• Access to free onsite baristas and cafe with daily lunch and breakfast
• Access to free onsite fitness center
• Commuter benefits

About insitro

insitro is a drug discovery and development company using machine learning (ML) and data at scale to decode biology for transformative medicines. At the core of insitro’s approach is the convergence of in-house generated multi-modal cellular data and high-content phenotypic human cohort data. We rely on these data to develop ML-driven, predictive disease models that uncover underlying biologic state and elucidate critical drivers of disease. These powerful models rely on extensive biological and computational infrastructure and allow insitro to advance novel targets and patient biomarkers, design therapeutics and inform clinical strategy. insitro is advancing a wholly owned and partnered pipeline of insights and therapeutics in neuroscience, oncology and metabolism. Since launching in 2018, insitro has raised over $700 million from top tech, biotech and crossover investors, and from collaborations with pharmaceutical partners. For more information on insitro, please visit www.insitro.com.