Job Title: Biostatistician — SMART Study Design

Work Location: Montgomery County, Maryland

Summary:

Seeking an experienced Biostatistician with expertise in Sequential Multiple Assignment Randomized Trial (SMART) design to support clinical development initiatives. This contract role focuses on adaptive methodologies and evidence-based treatment sequencing within complex therapeutic programs.

Responsibilities:

• Lead the statistical design and analysis of SMART trials, including adaptive interventions and dynamic treatment regimes.
• Develop and review statistical analysis plans, randomization schemes, and sample size justifications tailored to SMART frameworks.
• Collaborate with clinical, regulatory, and programming teams to ensure study designs align with regulatory expectations.
• Utilize advanced methods such as Q-learning, inverse probability weighting, and marginal mean weighting through stratification to estimate optimal treatment rules.
• Contribute to submission packages for regulatory filings and interact with regulatory agencies as required.
• Provide biostatistical input for protocol development, case report form design, and data monitoring committee charters.
• Support the integration of adaptive and platform trial methodologies into clinical development strategies.
• Ensure statistical deliverables meet project timelines and quality standards.

Qualifications:

• Advanced degree (MS or PhD) in Biostatistics, Statistics, or a related quantitative field.
• 5+ years of clinical trial experience in relevant settings.
• Hands-on experience designing or analyzing SMART trials.
• Proficiency in SAS and/or R, including simulation and dynamic treatment regime estimation packages.
• Strong foundation in adaptive and platform trial methodologies.
• Experience with regulatory submissions is strongly preferred.

Published Category: Biostatistics & Data Sciences