Associate Biostatistics Director (Remote)

Job summary

Lead the comprehensive Biostatistics efforts for assigned programs within a therapeutic area, defining statistical strategies and ensuring the application of suitable methodologies for study design and data analysis in clinical trials and regulatory submissions.

Qualifications

• PhD or MS in Biostatistics, Statistics, or a related field.
• At least 8 years of experience in clinical trial statistics, preferably in a pharmaceutical or CRO environment.

Responsibilities

• Direct statistical strategy for planning and execution of studies, participating in governance reviews and cross-functional teams.
• Provide statistical thought leadership for innovative study designs and clinical development plans, including Go-No Go criteria and success probability calculations.
• Oversee project-wide planning of analyses and ensure timely delivery of interim and final results, including integrated analyses for submissions.
• Represent Biostatistics in discussions with regulatory authorities (e.g., FDA, EMA, PMDA).
• Interpret analysis results and ensure accuracy in study reports and regulatory documents.
• Prepare abstracts, posters, presentations, and reports to communicate clinical program results to diverse stakeholders.

Skills

• Advanced proficiency in SAS and R for data analysis and statistical programming.
• Experience with Bayesian methods, predictive modeling, and simulation techniques.
• Proven ability in strategic study design, including adaptive designs and sample size calculations.
• Familiarity with regulatory guidance on statistical methodologies.
• Strong communication skills for presenting statistical concepts to cross-functional teams.

Tools

• SAS, R