Staff Biostatistician

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

📋 Description

• Act as the lead Biostatistician, providing technical expertise as an essential team member for complex clinical studies, which includes offering statistical oversight and participating in relevant project meetings.

• Deliver expert-level statistical guidance and thought leadership for innovative study designs and clinical development plans, encompassing endpoint selection and powering.

• Draft the statistical sections of clinical study protocols.

• Interpret analysis results and ensure the accuracy of reporting in study reports and regulatory documents.

• Conduct a comprehensive statistical review of Tables, Figures, and Listings (TFLs) for clinical studies.

• Oversee operational work with internal statistical programmers to guarantee timely and high-quality deliverables.

• Represent the Biostatistics team in communications with regulatory authorities (e.g., FDA) and during audits.

• Assist in the preparation of abstracts, oral presentations, manuscripts, and written reports by effectively communicating the results of clinical programs and studies to both internal and external stakeholders.

• Provide statistical expertise to both internal and external stakeholders (e.g., presentations/publications, Marketing, Health Economics & Reimbursement).

• Develop, maintain, and implement Standard Operating Procedures (SOPs), processes, standards, and work instructions related to biostatistics to ensure compliance, accuracy, efficiency, and optimization.

⛳️ Requirements

• A Master's degree or higher in Statistics, Biostatistics, or Mathematics.

• Over 10 years of experience in lead project roles as a statistician on clinical trial projects.

• In-depth understanding of the biostatistics processes and systems.

• Exceptional written and verbal communication skills, with the ability to professionally engage with all organizational levels to achieve deliverables.

• Strong interpersonal and relationship management abilities, including the capacity to proactively elevate and resolve cross-functional issues to meet project objectives.

• Comprehensive organizational, judgment, analytical, decision-making, and influencing skills.

• Proven leadership skills in project management.

• Expert knowledge of clinical trial design, with the ability to apply functional knowledge and methodologies to solve complex problems.

• Experience leading briefings and technical meetings for both internal and external stakeholders.

• Capability to build effective peer, cross-functional, and cross-business relationships to enhance best practice sharing and team effectiveness.

• Ability to excel in a fast-paced, dynamic, and ever-changing work environment.

• Strong programming skills in R (required) and Python (preferred), with demonstrated proficiency in literate programming (R markdown/Sweave).

🏝️ Benefits

• Equity

• Cash bonuses

• Comprehensive medical benefits

• Financial benefits