ClinChoice is looking for an Associate Director/Director Biostatistician to provide strategic and technical leadership for statistical aspects of our clinical programs. In this role, you will lead statistical strategy across multiple studies, from design to regulatory submission, contributing to our mission of accelerating the development of innovative drugs and devices for a healthier world.

What You'll Do

Provide statistical leadership across one or more clinical programs, including study design, analysis strategy, and interpretation of results.
Lead the development and review of statistical deliverables, including protocols, SAPs, TFLs, ISS/ISE, and regulatory submission materials.
Serve as a key statistical representative in cross-functional team discussions and governance meetings.
Ensure statistical approaches comply with regulatory standards and industry best practices.
Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance.
Collaborate with cross-functional teams, including Clinical, Programming, Data Management, and Regulatory.
Provide guidance and oversight to statistical programmers as needed.
Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders.
Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs.

What We're Looking For

MS or PhD in Statistics, Biostatistics, or a related field.
10+ years of experience in biostatistics within the pharmaceutical, biotechnology, or CRO industry.
Strong experience supporting clinical trials across all phases.
Excellent communication skills, with the ability to clearly explain statistical concepts to non-statistical stakeholders.
Strong experience in Immunology clinical studies.
Proven ability to lead projects and studies independently.