Lead the full scope of Biostatistics activities for assigned clinical programs or indications
Define and execute statistical strategies for clinical trials and regulatory submissions
Design clinical studies, including endpoints, estimands, and sample size calculations
Serve as statistical lead on Study Executive Teams and Clinical Development Teams
Provide quantitative input into clinical development plans, including Go/No-Go criteria and probability of technical success
Ensure quality and timely delivery of statistical outputs, including interim, final, and integrated analyses
Contribute to regulatory submissions (e.g., NDA) and represent Biostatistics in interactions with FDA
Collaborate cross-functionally with Clinical, Medical, and Regulatory
Oversee CROs and/or internal teams; ensure quality, timeliness, and compliance of deliverables
Collaborate with internal leaders of Statistical Programming and Data Management
Supervise statistical programmers for QC and validation activities
Interpret analysis results and ensure accuracy in study reports, publications, and regulatory documents
Contribute to abstracts, posters, and presentations for internal and external stakeholders
Drive continuous improvement initiatives within Biostatistics and cross-functional processes

Requirements

PhD in Biostatistics, Statistics, or related field with ~8+ years of industry experience OR MS with ~11+ years of experience in drug development
Pharmaceutical/biotech industry experience required
Demonstrated experience providing statistical leadership at study or program level
Strong experience designing clinical trials and collaborating with cross-functional teams
Experience supporting regulatory submissions (NDA/BLA)
Experience interacting with regulatory authorities preferred
Experience overseeing CROs or external vendors
Experience supervising programming deliverables or QC activities
Strong knowledge of CDISC standards, data structures, and statistical methodologies
Working knowledge of SAS and/or R (oversight level, not heavy programming)
Experience with outcomes research preferred
Therapeutic area experience flexible; preference for chronic diseases or larger patient populations.

Benefits

Health insurance
Dental
Vision
Time off
401K

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

BiostatisticsStatisticsstatistical strategiesclinical trial designsample size calculationsregulatory submissionsCDISC standardsstatistical methodologiesSASR

Soft Skills

leadershipcollaborationcommunicationquality assurancecontinuous improvement

Certifications

PhD in BiostatisticsMS in related field