Associate Director, Biostatistics

Position Overview

The Associate Director of Biostatistics provides statistical support to clinical studies, including the design, analyses, and interpretation of clinical trials. This position collaborates closely with cross-functional teams and provides scientifically rigorous statistical expertise on projects and protocols in support of clinical development and for publication and presentation.

Responsibilities

• Apply rigorous statistical expertise to study design, statistical analysis plans, interpretation of results, project development plans, and regulatory issues.
• Provide strategic statistical input into clinical development plans and study-level decision-making, anticipating downstream regulatory and data implications to inform study design and overall development strategy.
• Plan, deliver, and communicate statistical analyses and scientific reports, including clinical trial and exploratory analyses, and support publications and scientific presentations.
• Own the timeliness and quality of study- and submission-level statistical deliverables on assigned projects. For outsourced studies, manage vendors and monitor their performance and adherence to project timelines.
• Ensure all study- and project-level statistical activities are conducted in compliance with relevant regulatory requirements (e.g., FDA regulations).
• Contribute to interactions with regulatory authorities (e.g., FDA, EMA), including statistical input for regulatory meetings, responses to health authority questions, and preparation for advisory committee meetings.
• Collaborate with internal partners (e.g., clinical development, clinical data management, statistical programming) to provide statistical support and help identify and resolve data issues.
• Develop and lead initiatives in process improvement, training, and standard development.
• Support ad hoc analyses and develop and validate programs for data analysis, reporting, and visualization.

Qualifications

• PhD or Master’s in Biostatistics, Statistics, or a related field.
• A minimum of 6 years (with a PhD) or 8 years (with a Master's) of biostatistics experience supporting clinical trials in the pharmaceutical, biotech, or CRO industry, or equivalent.
• A minimum of 2 years of leadership or people-management experience is preferred.

Knowledge and Skills

• Prior oncology clinical trial experience, including familiarity with standard response criteria (e.g., RECIST 1.1), oncology endpoints (e.g., overall survival, progression-free survival, objective response rate), and associated statistical methodology (e.g., survival/time-to-event analysis, group sequential and adaptive designs).
• Experience supporting regulatory submissions (e.g., NDA, BLA) is a strong plus.
• Experience managing CROs and external statistical vendors, including oversight of outsourced statistical deliverables, is a plus.
• Proficiency in statistical programming languages (e.g., SAS, R); experience using simulation to support trial design is a plus.
• Knowledge of CDISC data standards (SDTM and ADaM).
• Knowledge of drug submission requirements and relevant ICH and FDA/EMA guidelines, including the ICH E9(R1) estimand framework.
• Strong verbal and written communication skills, including the ability to convey complex statistical concepts to cross-functional, non-statistical audiences.
• Strong problem-solving skills and the ability to work both independently and collaboratively in a fast-paced environment.
• Strong attention to detail and a proven ability to manage multiple competing priorities.