Build and lead the biostatistics function, owning statistical strategy across regulatory submissions and clinical validation programs.
Compensation
The expected base salary range for this role is 180,000-210,000 reflecting a good faith estimate. Actual compensation may vary based on experience, qualifications, and other job-related factors. This role is also eligible for equity and 401(k) with company match.
Responsibilities
Own study design and Statistical Analysis Plans across the portfolio, including pivotal regulatory submissions
Develop analytical and clinical validation strategies for novel biomarker technologies
Serve as the statistical authority in FDA interactions
Drive prognostic and predictive signature development on our platform representations
Help shape how evidence is generated and communicated across publications and clinical strategy
Provide statistical leadership for clinical development and life-cycle management strategies for assigned projects.
Responsibilities
Provide expertise/lead regulatory submission and product life-cycle management strategy planning and implementation for assigned projects.
Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs.
Independently develop protocols and statistical analysis plans.
Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management.
Partner with other functions to create development strategies for assigned projects.
Requirements
MS in Statistics, Biostatistics, or a highly related field
PhD in Statistics, Biostatistics, or a highly related field
Provide statistical leadership for clinical development and life-cycle management strategies for assigned projects, including design, analysis, reporting, and regulatory submission.
Compensation
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Responsibilities
Provide expertise/lead regulatory submission and product life-cycle management strategy planning and implementation for assigned projects
Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs
Independently develop protocols and statistical analysis plans
Represent function/department on project team(s) to provide statistical input to compound/drug development
Partner with other functions to create development strategies for assigned projects
Requirements
MS in Statistics, Biostatistics or a highly related field
PhD in Statistics, Biostatistics or a highly related field
Lead scientific activities for clinical research programs supporting product development, regulatory approvals, post‑market evidence generation, and scientific communication.
Compensation
The base pay for this position is $78,000.00 – $156,000.00
Responsibilities
Lead development of clinical study protocols, protocol amendments, investigator brochures, case report forms, statistical assumptions, endpoint strategies, and clinical study reports.
Design prospective clinical studies, registries, observational studies, post‑market studies, and evidence‑generation programs supporting global regulatory and business objectives.
Serve as scientific lead for assigned clinical studies and provide strategic scientific direction throughout study planning, execution, analysis, and reporting.
Develop scientific rationale supporting study design, endpoint selection, evidence‑generation strategies, and clinical development plans.
Collaborate with biostatistics to review statistical analysis plans and interpret primary, secondary, subgroup, sensitivity, and safety analyses.
Requirements
Bachelor's degree in Life Sciences, Biological Sciences, Biomedical Sciences, Biomedical Engineering, Bioengineering, Public Health, Epidemiology, Nursing, Medicine, Pharmacy, or related scientific discipline.
Lead biostatistician overseeing complex clinical trial studies, managing statistical strategy, design, analysis, and regulatory submissions.
Responsibilities
Serve as lead statistician on complex, key client studies
Act as point-of-contact ensuring cohesive communication with sponsors and internal teams
Lead project-level statistical strategy from protocol/SAP planning through reporting
Develop sample size estimation, modeling approaches, adaptive or Bayesian frameworks, and innovative trial designs
Provide senior oversight for statistical deliverables including SAPs, randomization specifications, and statistical contributions to CSRs, publications, and regulatory documents
Requirements
Advanced degree (MS or PhD) in statistics or closely related field
Lead clinical science for late-stage respiratory studies, driving protocol development, data analysis, regulatory documentation, and cross-functional collaboration.
Locations (2)
Somerville, Massachusetts, United States
Andover, Massachusetts, United States
Compensation
$186,000—$279,000 USD
Responsibilities
Serve as clinical science lead and core member of clinical development team for one or more respiratory studies
Support day-to-day study execution, ensuring alignment with protocol, timelines, and regulatory requirements
Act as a key scientific contributor to late-stage protocols and regulatory submissions
Design and develop clinical trial protocols and associated documents
Drive development of clinical components of regulatory documents
Principal BiostatisticianValar Labs
Director, Clinical Scientist (Respiratory)Generate Biomedicines · Somerville, US+1 more