Associate Director, Biostatistics - Remote

Overview

The Associate Director, Biostatistics role will be responsible for overseeing statistical activities for multiple clinical studies and/or a clinical program, participating study designs and protocol development, ensuring compliance with SOPs to produce quality and timely deliverables.

In Short

• Serve as a lead statistician and manage statistical efforts for multiple clinical studies
• Contribute to clinical protocol development, including authoring of the section on statistical methods
• Author statistical analysis plans for studies and/or ISS/ISEs
• Review CRF designs to ensure data collection meets study objectives
• Provide statistical input to data monitoring committee (DMC) charters
• Work with statistical programmers or CROs to generate tables, figures, and listings
• Support ongoing safety review and DMC review of clinical development programs
• Perform ad hoc and exploratory statistical analyses as needed
• Contribute to clinical study reports and author statistical sections
• Support regulatory submissions as needed

Requirements

• PhD in statistics or a related field with at least 6 years of clinical trial experience
• In-depth knowledge of FDA, EMA, and ICH regulations and guidelines
• Experience with BLAs, MAAs, and other regulatory submissions is a plus
• Proficient in statistical programming (SAS required, R a plus)
• Experience with trial design software (e.g., EAST)
• Extensive experience with ADaM and SDTM
• Good communication skills and ability to work with cross-functional teams
• Good organizational skills to multi-task in a fast-paced environment
• Good analytical and problem-solving skills
• Positive, outgoing, and collaborative attitude

Benefits

• Respectful and inclusive work environment
• Opportunity to work on innovative gene therapies
• Encouragement of personal and professional growth
• Collaborative team culture
• Commitment to diversity and equal opportunity