Biostatistics, Associate Director (Remote)
About the position
Responsibilities
• Assumes major responsibilities for clients and for the client's projects.
• Assists Project Management with financial tracking of projects.
• Assumes leadership of statistical and programming work on projects.
• Serve as the primary statistical liaison for Data Monitoring Committees, as assigned, ensuring objective and independent statistical support.
• Lead the development and execution of analyses for DMC review, ensuring adherence to prespecified statistical analysis plans (SAPs) and charters.
• Provides statistical consulting services as needed in area of expertise.
• Provide independent and unblinded statistical support for DMC meetings, preparing interim reports, safety summaries, and efficacy analyses.
• A member of professional societies, attends meetings of these societies and may be an active member of professional societies.
• May serve as a DMC/DSMB statistician.
• Maintain high standards of confidentiality and integrity when handling unblinded data.
• Remain abreast of current advances in biostatistics, clinical trial design, and applicable regulatory guidance.
• Guide and mentor junior biostatisticians, as needed, in DMC-related methodologies and best practices.
• Represent Biostatistics, as assigned, in cross-functional meetings, Sponsor meetings and DMC member meetings.
• Other duties as assigned by supervisor.
Requirements
• Ph.D. in Biostatistics, Statistics, or a related field with 5+ years of experience OR Master's degree with 8+ years of experience in biostatistics within the pharmaceutical/biotech industry.
• At least eight years of post-Master's industry experience in clinical trials.
• Strong leadership, communication and presentation skills.
• Strong ability to effectively communicate complex statistical concepts to non-statisticians, including clinicians and regulatory reviewers.
• Organizational skills with the ability to manage multiple projects and priorities simultaneously.
• Demonstrated ability to work independently and collaboratively in a cross-functional environment.
• Strong expertise in interim analysis methodologies, adaptive designs, and statistical monitoring approaches, preferred.
• Proficiency in SAS, R, or other statistical programming tools for clinical trial analysis.
Benefits
• Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts
• Employee Assistance Programs and additional work/life resources
• Referral Bonuses and Tuition Reimbursement
• Flexible PTO
• Volunteer Time Off to benefit the community
• Opportunities for career development with on-the-job training, certification assistance, and continuing education reimbursement
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