Associate Director, Biostatistics

Clinical Outcomes Solutions

. Lead statistical activities for assigned clinical trials, mainly Phase 3, from protocol design through reporting of results .

Posted 10/28/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in leading statistical activities for clinical trials, particularly in Phase 3, utilizing SAS and R for data analysis and quality control. Strong knowledge of regulatory guidelines and experience in cross-functional collaboration to ensure timely and accurate trial delivery.

Highest-signal resume keywords

Master's Degree In Statistics7+ Years Experience In Clinical TrialsProficient In SAS And RStrong Knowledge Of Adaptive DesignExperience With EMA/FDA/ICH Guidelines

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisSample Size CalculationSAP DevelopmentMachine Learning AlgorithmsDeep Learning AlgorithmsInferential Statistical AnalysesModelling/SimulationDatabase Lock CoordinationTLF ReviewQC Of Datasets

Soft Skills

Excellent Communication SkillsStrong Organizational SkillsProject Management SkillsAbility To Work IndependentlyEffective Stakeholder Interaction

Industry Keywords

Clinical TrialsPharmaceutical IndustryBiotech IndustryHematology StudiesDrug Development ProcessCross-Functional CollaborationRegulatory ExpectationsTrial DeliveryStatistical MethodsCount Data

About the role

Key responsibilities & impact

Lead statistical activities for assigned clinical trials, mainly Phase 3, from protocol design through reporting of results
Represent the Statistics function on cross-functional trial teams
Oversee internal programming activities and/or CRO contributions
Contribute to or lead database lock, submission activities, safety reporting, ad hoc requests, and responses to regulatory questions
Collaborate with clinical, data management, programming, and other stakeholders to develop and finalize study outputs
Use SAS and/or R for QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, and exploratory analyses
Coordinate statistical activities across studies to align objectives, ensure consistency, and deliver on time
Formulate integrated analytical approaches, apply statistical methods and machine learning/deep learning algorithms, and automate repeatable processes

Requirements

What you’ll need

Master’s degree in Statistics or related quantitative discipline; PhD preferred
7+ years of experience supporting clinical trials in the pharmaceutical/biotech industry
Solid recent experience (≥3 years) in Phase II–III studies, including SAP development, sample size calculation, and TLF review
Strong knowledge of adaptive design, group sequential and statistical methods of count data
Prior experience on Hematology studies preferred
Good understanding of the drug development process and cross-functional interfaces
Experience supporting end-to-end trial delivery, from protocol input through CSR contributions
Working knowledge of EMA/FDA/ICH guidelines and regulatory expectations for clinical trials and submissions
Proficient in SAS and/or R for QC of statistical outputs and collaboration with programming teams
Excellent and effective communication skills and ability to interact effectively with cross-functional stakeholders and external partners
Strong organizational and project management skills
Demonstrated ability to work independently, take ownership and be accountable for study-level statistical activities and deliverables

Benefits

Comp & perks

Consistent training, development and support
Significant professional growth opportunities