Associate Director, Biostatistics

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead statistical functions for designated clinical trials, primarily Phase 3, from protocol formulation through the reporting of findings.

• Act as the Statistics representative on cross-functional trial teams.

• Supervise internal programming tasks and/or contributions from Contract Research Organizations (CROs).

• Participate in or oversee database locking, submission processes, safety reporting, ad hoc inquiries, and responses to regulatory inquiries.

• Collaborate with clinical, data management, programming, and other key stakeholders to create and finalize study outputs.

• Utilize SAS and/or R for quality control of datasets and deliverables, inferential statistical analyses, modeling/simulation, and exploratory analyses.

• Coordinate statistical activities across various studies to align goals, ensure consistency, and meet deadlines.

• Develop integrated analytical strategies, apply statistical techniques and machine learning/deep learning algorithms, and automate repetitive processes.

⛳️ Requirements

• Master’s degree in Statistics or a related quantitative field; PhD is preferred.

• Over 7 years of experience in supporting clinical trials within the pharmaceutical/biotech sector.

• Substantial recent experience (≥3 years) in Phase II–III studies, including the development of Statistical Analysis Plans (SAP), sample size calculations, and review of Tables, Listings, and Figures (TLF).

• Strong understanding of adaptive design, group sequential methods, and statistical techniques for count data.

• Previous experience in Hematology studies is preferred.

• Good grasp of the drug development process and cross-functional interactions.

• Experience in delivering end-to-end trial processes, from protocol input to Clinical Study Report (CSR) contributions.

• Familiarity with EMA, FDA, and ICH guidelines and regulatory standards for clinical trials and submissions.

• Proficient in SAS and/or R for the quality control of statistical outputs and in collaborating with programming teams.

• Exceptional communication skills, with the ability to engage effectively with cross-functional stakeholders and external collaborators.

• Strong organizational and project management capabilities.

• Proven ability to work independently, take initiative, and be accountable for study-level statistical tasks and deliverables.

🏝️ Benefits

• Consistent training, development, and support.

• Significant opportunities for professional growth.