Biostatistics Associate Director: Clinical Development Lead

Celldex Therapeutics, Inc.; Needham (MA); On-site; USD 154,000 - 200,000; Full time

Job summary

Celldex Therapeutics, Inc. in Needham, MA seeks an Associate Director, Biostatistics to provide statistical leadership for assigned clinical development programs from design to regulatory submission.

You will partner with Clinical Development and cross-functional teams, shaping trial design, endpoints, estimands, and analysis plans. The role entails independent ownership of statistical aspects, mentorship within Biostatistics, and guiding regulatory strategy and CRO oversight in a dynamic

Qualifications

• PhD or MS in Biostatistics or a closely related quantitative discipline.
• 5+ years of relevant industry experience with a PhD or 8+ years with an MS.
• Experience providing statistical leadership for clinical trials and regulatory submissions preferred.

Responsibilities

• Serve as the statistical lead for assigned clinical development programs and/or clinical trials from protocol development through database lock, analysis, clinical study report, and regulatory submission.
• Provide statistical input into development strategy including study design and sample size, endpoints selection, estimands, analytic methods, and missing-data strategies.
• Develop and/or review Statistical Analysis Plans (SAPs), TLF shells, statistical programming specifications, and other statistical documents.
• Lead statistical analyses and interpretation of clinical trial data; support publications based on trial data.
• Provide statistical expertise and leadership for regulatory submissions, briefing documents, responses to regulatory questions, and health authority interactions.
• Oversee CRO statistical deliverables, timelines, quality, and resource requirements; ensure SAP-compliant analyses.

Skills

Statistical leadership

Clinical trial design

Communication skills

Independent work

Education

PhD in Biostatistics

MS in Biostatistics

Tools

SAS

Regulatory submissions

Job description

Celldex Therapeutics, Inc. in Needham, MA seeks an Associate Director, Biostatistics to provide statistical leadership for assigned clinical development programs from design to regulatory submission.

You will partner with Clinical Development and cross-functional teams, shaping trial design, endpoints, estimands, and analysis plans. The role entails independent ownership of statistical aspects, mentorship within Biostatistics, and guiding regulatory strategy and CRO oversight in a dynamic