Senior Biostatistician

Therapeutics Inc.

. Lead and manage the statistical aspects of assigned project portfolios .

Posted 10/6/2026full-timeRemote • California • United StatesSenior💰 $120,000 - $140,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical analysis and programming for clinical trials, with a strong focus on SAS programming, CDISC standards, and regulatory compliance. Proven ability to manage project portfolios, collaborate with cross-functional teams, and deliver high-quality results under GCP, FDA, and ICH guidelines.

Highest-signal resume keywords

SAS ProgrammingStatistical AnalysisCDISC Standards ImplementationClinical Data ManagementRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisSample Size CalculationStatistical MethodologiesStatistical Analysis Plans (SAPs)Database QA AuditsSDTM SpecificationsADaM SpecificationsProgramming TechniquesStatistical ReportingClinical Study Design

Soft Skills

Problem-SolvingOrganizational SkillsWritten CommunicationOral CommunicationAttention to Detail

Tools & Technologies

SASStatistical SoftwareDatabase Management SystemsClinical Trial Management Systems

Industry Keywords

GCPFDAICH GuidelinesClinical TrialsRegulatory Submissions

About the role

Key responsibilities & impact

Lead and manage the statistical aspects of assigned project portfolios
Oversee and develop statistical and programming techniques to ensure quality and timely delivery of results
Contribute to statistical sections of study protocols
Perform sample size calculations
Develop randomization specifications, plans, and schedules
Review statistical input into case report forms, annotated case report forms, and database documentation
Author Statistical Analysis Plans for studies and project deliverables
Research, develop, and apply statistical methodologies and processes
Develop, review, and provide input into SDTM and ADaM dataset specifications
Create table and listing shells according to SAPs
Generate database listings for database QA audits
Assist data management and trial management teams with database lock preparation
Write or supervise SAS programming and QC for SDTM and ADaM datasets, tables, figures, and listings for clinical study reports
Perform statistical analyses and interpret results
Collaborate with medical writers on integrated clinical study reports
Contribute to regulatory submissions, including ISS and ISE development and responses to regulatory questions
Interact with Clinical Development Team members to support client satisfaction
Participate in Clinical Development Team and client meetings
Help build departmental infrastructure, programming standards, SAS macro and program libraries, and workload forecasts

Requirements

What you’ll need

Master’s or Doctoral level degree in statistics
At least 5 years of experience performing statistical analysis and reporting for clinical trials
Thorough understanding of clinical data management and analysis requirements under GCPs, FDA, and ICH guidelines
Excellent problem-solving, organizational, written, and oral communication skills
Ability to manage multiple priorities with strong attention to detail
Strong computer proficiency
SAS programming skills
Experience implementing CDISC standards end-to-end
Ability to perform statistical analyses of clinical data and prepare written interpretations of statistical results
Knowledge of core technical and regulatory requirements
Experience in the design, analysis, and reporting of clinical studies
Strong communication, collaboration, and teamwork skills

Benefits

Comp & perks

Equal employment opportunities
Collaborative, diverse, and respectful work culture
Continuous learning and professional growth opportunities