Lead Clinical Statistician

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the statistical strategy for Phase I-IV clinical trials.

• Offer statistical insights into clinical development strategies, study design, and protocol formulation.

• Develop suitable statistical methodologies and randomization strategies.

• Write and evaluate: Statistical Analysis Plans (SAPs), Clinical Study Reports (CSR), Integrated Summary of Safety (ISS), and Integrated Summary of Efficacy (ISE).

• Assess outputs from statistical programmers, including Tables, Figures, and Listings (TFLs), ADaM datasets, and analysis deliverables.

• Analyze study outcomes and convey findings to clinical, scientific, and executive stakeholders.

• Work closely with Clinical Operations, Data Management, Medical Writing, and Regulatory Affairs teams.

• Act as the representative for the Statistics team in cross-functional project groups.

• Oversee external Contract Research Organizations (CROs) and statistical vendors, ensuring adherence to quality, timelines, and regulatory standards.

• Assist in regulatory submissions and facilitate communication with the FDA, EMA, and other health authorities.

• Ensure statistical outputs align with ICH, GCP, and applicable regulatory guidelines.

• Promote ongoing enhancement of statistical standards, processes, and best practices.

• Mentor and lead fellow statisticians.

⛳️ Requirements

• In-depth knowledge of statistical methodologies applicable to clinical trials.

• Experience in reviewing outputs generated by SAS or R.

• Familiarity with Bayesian methodologies or adaptive designs is a plus.

• Knowledge of survival analysis, mixed models, and longitudinal data analysis.

• Proven experience in interpreting complex clinical datasets.

• Understanding of real-world evidence and observational analyses is beneficial.

• MSc or PhD in Statistics, Biostatistics, Mathematics, or a related quantitative field.

• Experience in a fast-paced biotech environment (or relevant experience in Pharma/CRO).

• Extensive experience in leading statistical efforts for clinical development programs.

• Strong grasp of clinical trial methodologies and adaptive study designs.

• Experience in supporting regulatory submissions.

• Comprehensive knowledge of ICH E9, CDISC standards (ADaM/SDTM), GCP, and statistical guidance from the FDA and EMA.

• Experience in collaboration with external CROs and vendors.

• Excellent communication and stakeholder management abilities.

🏝️ Benefits

• Attractive benefits package available.