Associate Director, Biostatistics

Clinical Outcomes Solutions

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

Posted 10/28/2026full-timeRemote • United States, United KingdomSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in leading statistical activities for clinical trials, particularly in Phase II–III studies, utilizing SAS and R for data analysis and ensuring compliance with regulatory guidelines. Strong project management and communication skills are essential for collaborating with cross-functional teams and delivering high-quality study outputs.

Highest-signal resume keywords

SAS ProgrammingR ProgrammingClinical Trial ManagementStatistical Analysis Plan (SAP) DevelopmentRegulatory Compliance (EMA/FDA/ICH)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical MethodsSample Size CalculationInferential Statistical AnalysesMachine LearningDeep Learning AlgorithmsDatabase Lock ActivitiesSafety ReportingTLF ReviewAdaptive DesignGroup Sequential Methods

Soft Skills

Effective CommunicationOrganizational SkillsProject ManagementIndependenceAccountability

Certifications & Qualifications

Master’s Degree in StatisticsPhD in Statistics (Preferred)

Industry Keywords

Clinical TrialsPharmaceutical IndustryBiotech IndustryHematology StudiesDrug Development Process

About the role

Key responsibilities & impact

Lead statistical activities for assigned clinical trials, mainly Phase 3, independently from protocol design to reporting of results
Represent the Statistics function on cross-functional trial teams
Oversee internal programming activities and/or CRO contributions on assigned clinical trials
Contribute to or lead database lock and 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 in line with regulatory and protocol requirements
Use SAS and/or R for QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, and exploratory analyses
Coordinate statistical activities across studies within the assigned project to align objectives, ensure consistency, and deliver on time
Formulate integrated analytical approaches, mine data sources, and use statistical methods, machine learning, and deep learning algorithms to discover actionable insights and automate 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
Opportunity to work with autonomy and ownership
Opportunity to leverage experience and utilize advanced statistical methods