Position Details

Salary $195K – $253K USD / year

Type Full-Time

Experience senior

Exp. Years 5+ years (PhD) / 8+ years (MS) / 10+ years (Bachelor's)

Education Bachelor's degree or higher (MS/PhD preferred)

Category Healthcare & Medical

About this role

Lead biostatistics efforts for virology studies, providing statistical input for trial design, data analysis, and regulatory submissions.

Key Responsibilities

Act as biostatistics lead on studies; lead statistical analyses and IP submissions; oversee safety monitoring analyses; collaborate on protocol design; provide statistical input for publications and regulatory docs

Technical Overview

Utilizes R/Shiny and SAS for analyses; supports regulatory documentation; collaborates across functions to ensure compliant statistical approaches.

Ideal Candidate

The ideal candidate is an experienced biostatistician with leadership in virology studies, capable of guiding trial design and regulatory submission processes.

Must-Have Skills

Bachelor's degree or higher in a quantitative field5+ years of experience in biostatistics (with PhD) or 8+ (MS) or 10+ (Bachelor's)

Nice-to-Have Skills

Experience developing software/tools to support statistical analysis using R/ShinyAbility to design multiple statistical analysis strategiesKnowledge of FDA/EMA regulationsICH guidelinesGCPStrong communication and organizational skills

Tools & Platforms

RShinySASTableauPower BI

Required Skills

biostatisticsstatistical analysistrial designtrial endpointsdata interpretationRShinySASregulatory knowledgeFDAEMAICH guidelinesGCPcross-functional collaborationdata management

Hard Skills

RShinySASTableauPower BISQLStatistical SoftwareBiostatisticsTrial DesignRegulatory Submissions

Soft Skills

CommunicationLeadershipCollaborationOrganizational skills

Industry & Role

Industry Healthcare & Medical

Job Function Provide biostatistical leadership for virology clinical studies and regulatory submissions

Role Subtype Biostatistics Lead

Tech Domains R, Shiny, SAS, Statistical Software, Tableau, Power BI

Keywords for Your Resume

Associate Director BiostatisticsBiostatisticsVirologyclinical studiestrial designstatistical analysis plansstatistical consultationR/ShinySASFDAEMAICH guidelinesGCPregulatory documentationstatistical softwaredata managementcross-functionalprotocol designdata analysistravelbiostatisticsRShiny

Deal Breakers

Must have 5+ years (with PhD) or 8+ years (with MS) or 10+ years (with Bachelor’s) of biostatistics experience, Bachelor’s degree or higher in a related field

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Associate Director, Biostatistics - Virology

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