Associate Director, Biostatistics
Location: Greater Philadelphia or Boston
Work Model: Hybrid (3 days onsite per week)

Our client is a global organization focused on advancing novel therapies for patients with rare diseases, with a clinical pipeline spanning multiple therapeutic areas and stages of development. Bringing a collaborative, project-driven structure, the organization is building a forward-looking team dedicated to delivering treatments that make a meaningful impact worldwide.

Currently they are seeking an Associate Director, Biostatistics to provide statistical leadership for clinical development programs. In this role, you will develop and implement statistical strategies for clinical trials and regulatory submissions, contributing to study design, data analysis, and reporting. This position offers strong visibility and requires close collaboration with cross-functional teams as well as interactions with regulatory agencies both in the U.S. and internationally. It’s a fantastic opportunity to become a part of a stable and growing group with a focus on innovation.

Responsibilities

• Lead the full scope of Biostatistics activities for a clinical development program within a therapeutic area.
• Define statistical strategy and ensure appropriate statistical methodologies are applied to study design and data analysis for clinical trials and regulatory submissions.
• Influence and contribute to clinical development plans and collaborate with cross-functional teams for governance reviews.
• Lead statistical strategy for study planning and execution as a member of the Study Executive Team and Clinical Development Team.
• Provide quantitative evaluation supporting clinical trials, regulatory submissions, and related documentation.
• Provide statistical thought partnership for innovative study design and clinical development plans, including Go/No-Go criteria and probability of technical success calculations.
• Plan and oversee program-wide statistical analyses and ensure the quality and timely delivery of interim and final results, including integrated analyses for submissions.
• Represent Biostatistics in interactions with regulatory authorities such as the FDA, EMA, and PMDA.
• Interpret analysis results and ensure accuracy in study reports and regulatory documents.
• Manage outsourcing operations or collaborate with internal statistical programmers within the program.
• Ensure the quality and timeliness of deliverables from CROs or functional service providers.
• Support or lead improvement initiatives within the department, organization, or broader pharmaceutical industry.
• Prepare abstracts, posters, oral presentations, and written reports to communicate results of clinical programs and studies to internal and external stakeholders.

Qualifications

• PhD or MS in Biostatistics, Statistics, or a related field
• PhD with 7 years of experience or MS with 9 years of experience in drug development
• Experience providing statistical leadership at the compound or indication level
• Demonstrated expertise in facilitating and optimizing clinical development strategies across early, late, or full development phases
• Experience supporting regulatory submissions
• Experience interacting with major regulatory authorities preferred
• Experience working with CROs or managing internal statistical deliverables preferred
• Demonstrated track record of innovation preferred

Core Competencies

• Familiarity with regulatory guidance and regulatory interactions
• Broad knowledge of clinical development processes
• Ability to work collaboratively and provide leadership in a matrix environment
• Strong written and verbal communication skills in English
• Good working knowledge of SAS and/or R
• Expertise across a range of statistical methodologies
• Experience applying innovative or creative statistical methods for clinical data analysis
• Familiarity with CDISC standards, statistical programming, and data standards