Senior Director, Biostatistics

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

📋 Description

• Oversee and coordinate statistical initiatives that support the design, execution, analysis, interpretation, and reporting of clinical trials.

• Assist with the statistical components of essential business and regulatory obligations.

• Contribute insights to program plans.

• Serve as the Biostatistics representative on cross-functional and intra-departmental teams and 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, compliant analysis datasets, and statistical evaluation of clinical trial data.

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

• Implement regulatory guidelines and statistical methodologies in clinical studies related to pharmaceutical development.

• Compose statistical reports and memos with minimal oversight.

• Validate complex datasets and summary tables.

• Prepare and document factual information.

• Organize and safeguard confidential project materials.

• Engage in communication with collaborators.

• Execute other assigned duties.

⛳️ Requirements

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

• PhD is preferred.

• A minimum of 12 years of experience in clinical trials.

• At least 5 years of experience in oncology clinical trials.

• Experience with solid tumor oncology is preferred.

• Experience with global NDA/BLA submissions is preferred.

• Experience designing, executing, and reporting Phase 3 oncology clinical trials in a lead statistician role is preferred.

• Strong proficiency in statistical software, including SAS and R.

• Familiarity with Splus and SQL is a plus.

• Thorough understanding of regulatory guidelines and statistical methodologies in pharmaceutical development.

• Ability to write and communicate clearly.

• Capacity to prioritize tasks and meet multiple deadlines.

• Excellent planning and organizational skills.

• Strong problem-solving capabilities.

• Ability to work independently while exercising judgment and decision-making skills.

• A mindset geared towards continuous improvement.

• Flexibility and willingness to learn and adapt to business and site requirements.

• 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.