Director, Biostatistics

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

📋 Description

• Lead and oversee statistical activities that support clinical studies.

• Assist in the design, execution, analysis, interpretation, and reporting of clinical trials.

• Effectively communicate data evidence.

• Aid in the statistical components of essential business and regulatory obligations.

• Contribute to program planning efforts.

• Act as a representative for Biostatistics in cross-functional and intra-departmental teams or working groups.

• Prepare or review clinical study protocols, case report forms, statistical analysis plans, and table shells.

• Develop or validate SAS programs for data management tasks, ensuring compliance with analysis datasets and statistical analysis of clinical trial data.

• Compile statistical sections of clinical trial reports and present findings to the team.

• Implement regulatory guidance and statistical methodologies in clinical studies within pharmaceutical development.

• Draft statistical reports and memos with minimal supervision.

• Validate intricate datasets or summary tables.

• Supervise CRO statistical deliverables.

• Organize and preserve confidential project materials.

• Execute other assigned duties.

⛳️ Requirements

• Master's Degree in statistics, biostatistics, or a closely related discipline.

• Over 7 years of experience in clinical trials.

• Minimum of 2 years of experience in oncology clinical trials.

• Preferred experience with solid tumor oncology and global NDA/BLA submissions.

• Preferred experience in designing, executing, and reporting phase 3 oncology clinical trials as a lead statistician.

• Strong familiarity with statistical software packages, including SAS and R.

• Knowledge of Splus and SQL is a plus.

• Strong ability to write and communicate clearly.

• Demonstrated sense of urgency and commitment to excellence.

• Capacity to prioritize tasks effectively to meet multiple deadlines.

• Excellent planning and organizational skills.

• Strong problem-solving capabilities.

• Ability to work independently and demonstrate sound judgment and decision-making skills.

• Mindset focused on continuous improvement.

• Flexibility and willingness to learn, adapting to business and site requirements in a dynamic setting.

• Maintain a positive, approachable, and professional demeanor.

🏝️ Benefits

• Annual performance incentive bonus.

• New hire equity package.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) match.

• Paid time off (PTO).

• Paid holidays.