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 Apply tot his job