ASSOCIATE DIRECTOR, BIOSTATISTICS DCRI

Primary Responsibilities and Tasks

• Ensures effective management and oversight for the portfolio.
• Ensures risk, quality, scope, budget and timelines are managed for the portfolio.
• Takes a leading role in developing and maintaining standard operating procedures related to product lines.
• Identifies operational problems, issues, obstacles, and barriers across projects that include targeted product line; identify trends and takes corrective actions and implements improvement.
• Participates in DCRI-wide initiatives and meetings.
• Understands and proactively remains abreast of guidelines from the FDA, NIH, ICH, EMEA, IRB, HIPAA, or other regulatory agency as they apply to statistics, programming, and handling of clinical trial and DSMB data.
• Demonstrates a solid understanding of the clinical drug and/or device development process, and maintains this evolving knowledge base into the future.
• Supports or leads communications between assigned product team(s) and functional management. Builds/drives cross-functional relationships and collaboration.
• Maintains expected financial projections, report/escalate projects at risk, and work within Biostatistics and across functional groups to make changes where necessary.
• Develops and implements team-specific orientation programs for new employees.
• Contributes to development of career paths and ongoing training and education of staff.
• Communicate goals, policies, procedures, and priorities to staff.
• Maintain appropriate utilization of resources and adherence to targets.
• Shares solid understanding of clinical research and the clinical drug and/or device development process and maintains this evolving knowledge base into the future.
• Provides statistical leadership for all assigned team projects with regard to statistical analysis and participation in multi-center clinical trials and projects primarily within product line.
• Partner with other functions to create strategies for assigned projects.
• Develops strategy for data presentation and inference. Ensures appropriate interpretation of statistical deliverables in collaboration with other functions.
• Proposes novel statistical methodological approaches leading to improvement in the efficiency and sensitivity of study results within product line. Determines the need for development of novel statistical methodology.

Requirements and Specifications

• Education/Experience: Bachelor's degree required and nine years of relevant experience to include 4 years in leadership roles. OR An equivalent combination of relevant education and/or experience.
• Preferred Qualifications: Master’s or doctoral degree in biostatistics, statistics, or a related field, with at least two years of experience serving as a statistician on clinical trials, and a demonstrated record of progressively responsible roles in academic and/or industry settings.
• Knowledge, Skills and Abilities: Excellent interpersonal, communication, collaborative, and presentation skills; familiarity with a range of statistical software (e.g., R, SAS, NQuery, EAST, PASS) with fluency in a core language such as R or SAS; strong statistical knowledge and analytical skills; experience with safety data, randomization schemes, Data Monitoring Committees and working with the NIH; excellent organizational skills, demonstrated ability to lead in a team environment, and an ability to supervise and delegate tasks; excellent working knowledge of clinical, operational and statistical issues as they pertain to the operations and analyses of clinical trials.
• Registration, Certification or Licensure: None required.