Director, Biostatistics

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

📋 Description

• Design and implement clinical trials.

• Conduct thorough data analysis.

• Assist in regulatory interactions.

• Supervise activities of Contract Research Organizations (CROs).

• Validate Tables, Listings, and Graphs (TLGs) as well as analysis datasets.

• Collaborate as a coauthor on manuscripts.

• Partner with statisticians to enhance process development, oversee internal contractors, and manage team growth and development.

• Translate strategic objectives of the department into actionable operational goals for teams throughout various study phases and compounds.

• Manage numerous, extensive, and intricate biostatistics projects through effective operational oversight of deliverables.

• Create and review study documents, statistical analysis plans, and final study reports.

• Work collaboratively with clinical, project management, data management, CRO, and vendor teams.

• Act as the lead statistician for global registration trials.

• Develop processes to nurture and grow biostatistics team talent.

• Direct global submission activities and assist with submission strategies and regulatory communications.

• Innovate and design efficient study methodologies that support clinical development and regulatory approval.

• Lead the evaluation and selection of strategic and large vendor partners.

• Contribute to the development of Standard Operating Procedures (SOPs), templates, and work instructions related to Electronic Data Capture (EDC) studies, FDA requests, independent validation, and biostatistics processes.

• Guide biostatistics experts in goal setting, performance management, employee engagement, and professional development.

• Oversee budget management within the area.

⛳️ Requirements

• Bachelor's degree (Master's degree preferred) with 10+ years of pertinent experience.

• Preferred experience in the Life Sciences industry.

• Possession of a Ph.D. in Biostatistics or a related field.

• Proven track record in directing multiple complex projects from inception to completion as a subject matter expert in Biostatistics.

• Strong publication history that showcases relevant experience.

• Demonstrated expertise in applying statistical methodologies across various aspects of pharmaceutical biostatistics.

• Comprehensive understanding and experience of the clinical development process.

• Proven ability to build internal and external networks while contributing as a thought leader.

• (For People Leaders/Directors) Experience in directly leading and managing a team with operational oversight, including budgetary and resource responsibilities.

• Documented success in previous or comparable roles.

• Proficient biostatistical skills.

• Excellent communication skills and ability to influence across functions.

• Strong critical thinking abilities and business agility.

• Knowledge of industry regulations.

• Experience in mentoring and developing personnel.

• Proficient in project management.

• Skilled in statistical programming.

• Experience in vendor management.

• Participation in E-Verify and employment eligibility verification for new hires in the United States.

🏝️ Benefits

• Eisai Inc. Annual Incentive Plan.

• Eisai Inc. Long Term Incentive Plan.

• Employee benefit programs offered by the company.

• Additional benefits may be available for this position.