Associate Director, Biostatistics FSP

Responsibilities

• Lead statistical activities for assigned Clinical Trials (mainly Phases 3) independently from protocol design to reporting of results.
• Represent Statistics function on cross-functional trial teams and collaborate effectively with all cross-functional stakeholders.
• Oversight of internal programming activities and/or CRO contributions on assigned clinical trials and other activities.
• Contribute to or lead other activities from a statistical perspective as appropriate, including database lock and submission activities, safety reporting, ad hoc requests, and respond to regulatory questions.
• Collaborate closely 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 purposes like QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, exploratory analyses etc.
• Coordinate statistical activities across studies within the assigned project, ensuring alignment of objectives, consistency of approach, and on-time delivery.

Qualifications

• 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 and 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 (clear, concise, and professional) and a 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