Lead Biostatistician, Biostatistics, R&D

Orion

Lead Biostatistician providing strategic statistical leadership for oncology drug development programs across Phase I–III clinical development. Responsible for executing statistical strategies to support study design and regulatory submissions.

Posted 7/10/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesSenior💰 $130,000 - $300,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in biostatistics leadership within oncology, with a strong focus on regulatory submissions and advanced statistical methodologies. Proven ability to lead clinical development plans and adopt AI-enabled analytics for enhanced statistical workflows.

Highest-signal resume keywords

PhD In Statistics10+ Years In Clinical Drug DevelopmentRegulatory Experience (FDA, EMA, ICH)Advanced Statistical Approaches (Bayesian, Adaptive Designs)Leadership And Collaboration Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

BiostatisticsStatistical MethodologiesClinical Development PlansStudy DesignsAI-Enabled AnalyticsAutomationOncology ExpertiseRegulatory SubmissionsStatistical LeadershipQuality Expectations

Soft Skills

Leadership SkillsCollaboration Skills

Tools & Technologies

AI-Assisted Statistical Workflows

Industry Keywords

OncologyClinical Drug DevelopmentRegulatory Compliance

About the role

Key responsibilities & impact

Provide scientific and strategic biostatistics leadership for oncology portfolio
Contribute to clinical development plans and study designs
Serve as the lead statistician for development programs
Ensure delivery of biostatistics outputs in line with timelines and quality expectations
Provide statistical leadership for regulatory submissions
Define and standardize statistical methodologies
Lead adoption of AI-enabled analytics and automation

Requirements

What you’ll need

PhD or MSc in Statistics, Biostatistics, or a related field (PhD preferred)
10+ years of experience in clinical drug development, oncology preferred
Extensive regulatory experience (FDA, EMA, ICH)
Deep expertise in oncology
Strong command of advanced statistical approaches (e.g. Bayesian and adaptive designs)
Excellent leadership and collaboration skills
Understanding of AI-assisted statistical workflows

Benefits

Comp & perks

Continuous learning opportunities
Teamwork environment
Clear purpose in the work