Associate Director, Biostatistics

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

📋 Description

• Collaborate with diverse study and project teams to support hematology research.

• Engage with Clinical, Regulatory, Statistical Programming, Data Management, and fellow Research Scientists.

• Assess data and create as well as execute statistical analysis plans for clinical study reports and submissions to health authorities.

• Contribute content for manuscripts and presentations.

• Offer statistical assistance in the design and analysis of clinical trials.

• Oversee statistical tasks for clinical projects.

• Develop or assist in creating study protocols and statistical analysis plans.

• Identify suitable statistical methodologies for data analysis.

• Take part in database design meetings.

• Work together with statistical programming teams to ensure that programs fulfill analysis, SOP, and regulatory standards.

• Analyze and interpret data from clinical trials.

• Prepare both oral and written reports that convey clinical trial outcomes.

• Address queries related to study design, analysis, and interpretation from clinical monitors, regulatory agencies, and investigators.

• Engage in research activities that involve innovative statistical methodologies and clinical trial applications.

⛳️ Requirements

• PhD in Statistics or a related discipline with over 5 years of experience, or a Master’s degree with at least 8 years of experience in clinical drug development.

• Experience with clinical trials is mandatory.

• Familiarity with regulatory guidance is essential.

• Proficiency in SAS and/or R is highly desirable.

• Experience in oncology is preferred but not mandatory.

• Proven written and verbal communication skills.

• Ability to work collaboratively within a team as well as independently.

• Skills in interdependent and analytical thinking.

• Proficient in building strategic working relationships.

• Strong decision-making abilities.

• Travel is not required.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial positions.

• Eligibility for an incentive compensation plan for commercial positions.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Comprehensive medical insurance.

• Dental insurance coverage.

• Vision insurance options.

• 401(k) retirement plan.

• Flexible Spending Account/Health Savings Account.

• Life insurance benefits.

• Paid Time Off.

• Wellness programs.