Director/Sr. Director, Biostatistics

About Alto Neuroscience, Inc.

We are seeking an experienced and highly skilled Director, Biostatistics, to serve as the senior statistical voice across Alto's clinical development portfolio. In this individual-contributor leadership role, you will shape statistical strategy for novel CNS therapeutics utilizing a biomarker approach — with a focus on mood disorders — driving innovative trial design, rigorous analysis, and clear translation of complex methodology into decision-grade insight. Reporting to the Chief Medical Officer with a dotted line to the Chief Development Officer and VP Translational Medicine, you will partner across functions and own statistical strategy and execution as Alto advances its precision-psychiatry pipeline.

Primary Role

We are seeking an experienced and highly skilled Director, Biostatistics, to serve as the senior statistical voice across Alto's clinical development portfolio. In this individual-contributor leadership role, you will shape statistical strategy for novel CNS therapeutics utilizing a biomarker approach — with a focus on mood disorders — driving innovative trial design, rigorous analysis, and clear translation of complex methodology into decision-grade insight. Reporting to the Chief Medical Officer with a dotted line to the Chief Development Officer and VP Translational Medicine, you will partner across functions and own statistical strategy and execution as Alto advances its precision-psychiatry pipeline.

What you'll do

• Statistical Leadership & Strategy:
• Serve as the lead biostatistician across Alto's clinical development portfolio, contributing statistical strategy at the study and program level.
• Champion innovative trial designs (adaptive, group sequential, Bayesian, seamless Phase 2/3) suited to Alto's precision-psychiatry platform.
• Translate technical methodology into actionable recommendations for cross-functional leadership and external stakeholders.
• Foster a culture of methodological rigor, scientific curiosity, and continuous improvement.
• Protocol & Statistical Analysis Plan Development:
• Lead authorship/review of Statistical Analysis Plans (SAPs) and provide statistical input into protocol design, endpoint selection, sample size, randomization, and analytic strategy.
• Define handling of multiplicity including hierarchical plans, missing data, multiplicity, interim analyses, and pre-specified subgroup analyses for CNS clinical trials.
• Lead statistical considerations and questions for regulatory interactions.
• Provide statistical contributions to Clinical Study Reports (CSRs), other regulatory documents, and peer-reviewed publications.
• Vendor & CRO Oversight:
• Serve as Alto's primary statistical interface with statistical CROs, statistical modeling vendors, and statistical programming vendors, ensuring delivery of high-quality, regulatory-compliant analyses.
• Review vendor-produced tables, listings, and figures (TLFs), datasets, and analyses for accuracy, interpretability, and adherence to the SAP.
• Drive timely resolution of statistical issues across vendor partnerships and uphold standards for analytical reproducibility.
• Cross-Functional Collaboration:
• Partner closely with Clinical Development, Clinical Operations, Translational Medicine, Engineering, Regulatory Affairs, and Medical Writing to align statistical strategy with program goals.
• Contribute to integrated evidence-generation strategies, including biomarker and digital-endpoint analyses unique to Alto's platform.
• Represent biostatistics in cross-functional protocol design, data review, safety review, and decision-making meetings.
• Lead ongoing critical data reviews and statistical monitoring, along with Translational Medicine and Clinical Development, throughout the trial.
• Regulatory Compliance & Quality:
• Ensure all statistical activities comply with ICH-GCP, FDA, EMA, and CDISC standards (SDTM, ADaM).
• Support inspection-readiness, regulatory submissions, and statistical sections of briefing documents and advisory committee materials.
• Contribute to internal standards and best practices for biostatistics deliverables.
• Methodology & Innovation:
• Stay current with emerging methodology relevant to psychiatry, precision medicine, biomarker-stratified trials, and digital endpoints.
• Identify and pilot statistical approaches that strengthen Alto's ability to detect treatment effects in heterogeneous patient populations.
• Contribute to publications, conference presentations, and external scientific engagement.

Location

Preference is for the job to be located at the company headquarters in Mountain View CA, but remote work will be considered.

Salary Range

$220 - $260k *depending on qualifications and experience level

Travel Required

Occasional

Qualifications

• Minimum of 5 years of post-graduate biostatistics experience in pharmaceutical, biotechnology, or CRO environments, with hands-on contributions to Phase 1-3 clinical trials.
• Deep expertise in clinical trial design methodologies, including adaptive, group sequential, Bayesian, and seamless Phase 2/3 designs.
• Strong proficiency in SAS and/or R, with working familiarity in CDISC standards (SDTM, ADaM).
• Demonstrated ability to author Statistical Analysis Plans and contribute to protocols, CSRs, and regulatory submissions.
• Working knowledge of ICH-GCP, FDA, and EMA regulatory expectations for clinical biostatistics, including 21 CFR Part 11.
• Excellent communication skills, with proven ability to translate complex statistical concepts for non-statistical audiences.
• Comfortable operating in a fast-paced, science-first, cross-functional environment with high accountability and ownership.

Preferred Skills

• Prior experience supporting clinical development in CNS, psychiatry, or mood disorders.
• Publication record in clinical trial methodology.
• Experience with biomarker-stratified or precision-medicine trial designs.

Physical Demands & Work Environment

• Required to sit for prolonged periods of time.
• While performing the duties of this job, the noise level in the work environment is usually quiet.

Business Operations

Mountain View, CA