Associate Director, Biostatistics

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Lead statistical initiatives for assigned clinical trials, predominantly Phase 3, from protocol design through to result reporting.

• Represent the Statistics department on interdisciplinary trial teams.

• Supervise internal programming tasks and/or contributions from CROs.

• Participate in or lead database lock and submission processes, safety reporting, ad hoc requests, and responses to regulatory inquiries.

• Collaborate with clinical, data management, programming, and other stakeholders to create and finalize study outputs in accordance with regulatory and protocol standards.

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

• Coordinate statistical activities across studies within the assigned project to ensure aligned objectives, consistent methodologies, and timely delivery.

• Develop integrated analytical strategies, explore data sources, and apply statistical, machine learning, and deep learning techniques to uncover actionable insights 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 in the pharmaceutical/biotech sector.

• Strong recent experience (≥3 years) in Phase II–III studies, encompassing SAP development, sample size calculations, and TLF reviews.

• In-depth knowledge of adaptive designs, group sequential methods, and statistical techniques for count data.

• Previous experience with Hematology studies is preferred.

• Strong understanding of the drug development process and cross-functional interactions.

• Experience in supporting the complete trial delivery process, from protocol input to CSR contributions.

• Familiarity with EMA/FDA/ICH guidelines and regulatory expectations for clinical trials and submissions.

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

• Exceptional communication skills; ability to engage effectively with cross-functional stakeholders and external partners.

• Strong organizational and project management abilities.

• Proven capacity to work independently, take ownership, and be accountable for study-level statistical activities and deliverables.

🏝️ Benefits

• Consistent training, development, and support.

• Significant opportunities for professional growth.