Associate Director, Biostatistics

Our client is a well-funded, publicly traded clinical-stage biotechnology company developing a portfolio of novel biologic therapies targeting large immunology and inflammation indications. Their pipeline focuses on validated biological pathways and advanced antibody engineering designed to improve efficacy, durability, and dosing profiles compared to current therapies.

With multiple clinical-stage programs and a leadership team with a strong track record in drug development, the company is focused on delivering differentiated therapies for patients with significant unmet medical needs.

The organization offers a fast-paced, highly collaborative environment where employees have the opportunity to contribute meaningfully across programs and play a visible role in advancing innovative therapeutics.

Role Summary

The company is seeking an Associate Director of Biostatistics to serve as the statistical lead across one or more clinical development programs.

In this role, you will provide strategic and technical statistical leadership supporting study design, clinical trial execution, regulatory deliverables, and scientific publications. You will partner closely with cross-functional teams including Clinical Development, Clinical Operations, Data Management, and Regulatory Affairs.

You will also oversee external CRO and vendor biostatistics teams to ensure the successful execution and statistical integrity of clinical trials.

Key Responsibilities

• Serve as the statistical lead for one or more clinical development programs

• Provide expert input on clinical trial design, statistical methodology, and development strategy

• Author or review statistical sections of:

  • Clinical protocols

  • Statistical Analysis Plans (SAPs)

  • Clinical Study Reports

  • Regulatory submissions

  • Scientific publications

• Perform or review sample size calculations and power analyses

• Oversee CRO and vendor biostatistics activities including:

  • TFL development

  • Interim analyses

  • Data Monitoring Committee support

  • Database lock activities

• Contribute to regulatory interactions and submission preparation

• Conduct exploratory analyses and provide statistical support for internal and external presentations

• Evaluate innovative statistical approaches and study design methodologies

• Ensure timely delivery of high-quality statistical outputs across clinical programs

Ideal Candidate Profile

• PhD in Statistics or Biostatistics preferred

  • Candidates with an MS in Statistics, Biostatistics, or related field and significant industry experience will also be considered

• 8+ years of industry biostatistics experience supporting clinical trials

• Experience supporting Phase 2 and Phase 3 clinical studies

• Prior involvement in regulatory submissions preferred

• Experience working in matrixed clinical development environments

• Ability to communicate complex statistical concepts to cross-functional teams

• Experience managing CROs and external vendors

• Strong knowledge of:

  • Clinical trial statistical methodology

  • Adaptive and Bayesian trial design

  • Missing data imputation and multiplicity adjustments

  • Estimands and modern regulatory statistical frameworks

• Proficiency in SAS, R, or similar statistical programming tools

• Knowledge of CDISC standards including SDTM and ADaM

• Familiarity with ICH, FDA, and EMA regulatory guidance

• Experience designing and running clinical trial simulations preferred

• Remote position within the United States

• Approximately 10-15% travel for team meetings and key clinical development milestones

Compensation

The anticipated base salary range for this position is $195,000 – $215,000, depending on experience, background, and geographic location.

The role also includes a competitive bonus structure, equity participation, comprehensive health benefits, and generous paid time off.