Associate Director, Biostatistics

Overview

The Associate Director, Biostatistics will provide statistical leadership for assigned clinical development programs and studies, from study design through regulatory submission. The individual will serve as a key statistical partner to Clinical Development and cross-functional teams, providing strategic input on trial design, endpoints, estimands, statistical methodology, data interpretation, and regulatory strategy.

The Associate Director is expected to own the statistical aspects of assigned programs, lead statistical activities with a high degree of independence, and provide technical leadership and mentorship to other members of the Biostatistics organization. This role is well suited for an experienced biostatistician who can balance strategic thinking with hands-on statistical expertise in a dynamic biotechnology environment.

Responsibilities

• Serve as the statistical lead for assigned clinical development programs and/or clinical trials, providing leadership from protocol development through database lock, analysis, clinical study report, and regulatory submission.
• Provide statistical input into clinical development strategy, including development of study design and sample size, endpoints selection, estimands, analytic methods, and missing-data strategies.
• Develop and/or review protocols, Statistical Analysis Plans (SAPs), TLF shells, statistical programming specifications, and other statistical documents.
• Lead and/or oversee statistical analyses and interpretation of clinical trial data. Support the development of publications based on clinical trial data.
• Serve as the statistical representative on cross-functional study and program teams and act as a trusted statistical partner to Clinical Development and other functional leaders.
• Provide statistical expertise and leadership for regulatory submissions, briefing documents, responses to regulatory questions, and health authority interactions.
• Provide oversight of CRO statistical deliverables, timelines, quality, and resource requirements. Ensure appropriate implementation of statistical methodology per SAP requirements and quality of statistical analysis.
• Contribute to development and implementation of statistical standards, templates, processes, and best practices.
• Support the growth and development of the Biostatistics function and contribute to hiring and team development as appropriate

Qualifications

• PhD or MS degree in Biostatistics, Statistics, Mathematics, or a closely related quantitative discipline.
• 5+ years of relevant industry experience with a PhD or 8+ years with an MS, preferably within the pharmaceutical or biotechnology industry.
• Demonstrated experience providing statistical leadership for clinical trials and/or clinical development programs. Experience with NDA/BLA preparation and regulatory submissions is preferred.
• Strong knowledge of clinical trial design, statistical methodology, and regulatory principles.
• Hands-on experience with SAS and/or other statistical softwares and the ability to critically evaluate statistical programming outputs.
• Excellent written and verbal communication skills.
• Demonstrated ability to work independently and effectively in a fast-paced, resource-conscious biotech environment.
• Ability to manage multiple projects and priorities while maintaining high-quality deliverables.

Compensation Statement

The expected base salary for this position is: $153616.00 to $199501.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.