Job Title: Contract Associate Director, Biostatistics

Work Location: Remote

Summary:

This contract role offers the opportunity to provide statistical leadership and expertise for clinical development programs, supporting regulatory submissions and scientific publications. The position involves collaboration with cross-functional teams to ensure the statistical integrity of clinical trial deliverables and compliance with regulatory standards.

Responsibilities:

• Lead statistical activities for clinical studies, including study design, sample size calculations, and authoring or reviewing statistical sections in protocols and analysis plans.
• Develop and review randomization files, as well as create and specify tables, figures, and listings (TFLs) for clinical studies.
• Participate in the review of case report forms (CRFs) and other study documentation, and actively engage in study-related meetings.
• Collaborate with biometrics and cross-functional teams to ensure timely and high-quality deliverables for clinical projects.
• Ensure the statistical integrity of all deliverables and provide scientifically sound methodological input to meet project and regulatory requirements.
• Independently conduct data analyses and propose innovative statistical methodologies as needed.
• Contribute to the development and implementation of advanced statistical standards and methodologies.
• Author and review regulatory documents and scientific publications related to clinical trial data.

Qualifications:

• PhD in Statistics or Biostatistics with at least 5 years of post-graduate experience in clinical trials within the pharmaceutical or biotechnology industry, or a Master’s degree with at least 8 years of relevant experience.
• Significant experience as a key statistical contributor for NDA/BLA/MAA submissions, including direct regulatory interactions.
• Demonstrated experience as a study lead statistician, including authoring statistical analysis plans and TFL specifications.
• Proficiency in SAS and R programming; strong knowledge of CDISC standards (SDTM, ADaM) is highly preferred.
• Familiarity with ICH guidelines and regulatory authority guidance (FDA, EMA, etc.).
• Strong organizational, problem-solving, and prioritization skills with attention to detail.
• Experience in developing or applying advanced statistical methodologies is a plus.
• Pharmaceutical sponsor experience required; candidates with only academic or CRO backgrounds will not be considered.

Published Category: Biostatistics & Data Sciences