Associate Director, Biostatistics

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

📋 Description

• Lead statistical efforts for designated clinical trials, primarily Phase 3, from protocol design through to results reporting independently.

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

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

• Participate in or take charge of database lock and submission processes, safety reporting, ad hoc requests, and answers to regulatory inquiries.

• Collaborate with clinical, data management, programming, and other stakeholders to produce and finalize study outputs consistent with regulatory and protocol specifications.

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

• Coordinate statistical initiatives across studies within the assigned project to align goals, ensure uniformity, and meet deadlines.

• Develop integrated analytical strategies, extract data from sources, and apply statistical methods, machine learning, and deep learning algorithms to identify actionable insights and automate processes.

⛳️ Requirements

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

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

• Strong recent experience (≥3 years) in Phase II–III trials, including Statistical Analysis Plan (SAP) development, sample size calculations, and review of tables, listings, and figures (TLFs).

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

• Previous experience with Hematology studies is preferred.

• Solid understanding of the drug development process and various cross-functional interfaces.

• Experience in supporting the full lifecycle of trial delivery, from protocol input to Clinical Study Report (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 and the ability to interact effectively with cross-functional stakeholders and external partners.

• Strong organizational and project management capabilities.

• Proven ability to work independently, take ownership, and be accountable for statistical activities and deliverables at the study level.

🏝️ Benefits

• Consistent training, development, and support.

• Significant opportunities for professional growth.

• Chance to work with autonomy and ownership.

• Opportunity to leverage experience and apply advanced statistical methods.