ASSOCIATE DIRECTOR, BIOSTATISTICS DCRI

Associate Director, Biostatistics DCRI

The Associate Director of the Interventional Biostatistics team manages team operations, including personnel management, quality assurance, resource planning, and financial performance. This position ensures the delivery of effective statistical services for interventional clinical trial projects while cultivating a collaborative team environment. Additionally, the Associate Director represents the group in sponsor meetings and business development efforts, showcasing the team's expertise and ensuring that deliverables meet partner expectations. Responsibilities also include advancing the Interventional Biostatistics product line, mentoring team members, and engaging in cross-functional initiatives within DCRI.

Primary Responsibilities and Tasks:

• Operations Management: Ensures effective management and oversight for the portfolio. Ensures risk, quality, scope, budget and timelines are managed for the portfolio. Acts as a business partner with other DCRI/Duke groups etc. 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. Ensures that sample size estimates for proposals are conducted, mostly working with a faculty member. Support or lead communications between assigned product team(s) and functional management. Build/drive cross-functional relationships and collaboration.
• Personnel Management: Partners with the Director of Biostatistical Operations, the DCRI Data Science and Biostatistics Therapeutic Area Faculty Director and HR to develop a strategy for recruitment, mentoring and training that is aligned with DCRI clinical research priorities. Oversee recruitment and hiring of statistical staff within the team and participates in the recruitment process for the broader Biostatistics group. Manages staff performance: job descriptions, performance plans, coaching and feedback, performance evaluations, and development plans. Handles coaching and disciplinary actions, promotions, and transfers of direct reports while providing consultation for management of staff who are supervised by others. Collaborates with Director of Biostatistical Operations and other Biostatistics Associate Directors to ensure consistent employee expectations and treatment across managers within the Biostatistics department. 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. Monitor forecasts regarding workload volume and make recommendations regarding staffing requirements in order to fulfill project deliverables while ensuring optimal efficiency and quality.
• Business Development: Leads development and enhancements of the Interventional Biostatistics product line within Biostatistics. Provides consultation and assistance as needed to assist in recruitment and budgeting of new DCRI trial/projects. Represents the Biostatistics group in internal and external business development meetings, including presentations about the capabilities and operations of the Biostatistics group, for external clients in the pharmaceutical, medical device, biotechnology, or regulatory community. Raises internal awareness and understanding within DCRI faculty and staff of product line(s) and value to the DCRI. Develops and/or provides input into marketing materials (slide presentations, brochures, website materials) regarding statistical capabilities and services related to product line. Consults with Business Development to provide advice regarding the practicality and appropriateness of potential projects.
• Strategic Development: In collaboration with the Director of Biostatistical Operations, develops goals and objectives on an annual basis, and ensures alignment with the mission, vision, and goals of the DCRI. Assists in developing strategic plans for the future direction of the group to ensure DCRI's continued position as a leading ARO. Keeps abreast of emerging developments and trends in the field of clinical biostatistics, with special focus within the product line. Provides operational guidance and support to the department toward DCRI's mission of conducting innovative clinical research. Facilitates the identification and development of new services to be offered by the functional group in order to meet customer needs.
• Financial Management: Maintain expected financial projections, report/escalate projects at risk, and work within Biostatistics and across functional groups to make changes where necessary. Provide input into budgetary forecasts for functional group expenses (operating and capital) on an annual basis in collaboration with Biostatistics Leadership. Ensure appropriate utilization of resources and adherence to targets. Utilize DCRI tools to oversee financial aspects of projects and work with the respective teams to understand any concerns or areas that need attention.
• Sharing Knowledge and Serving as Resource: Serve as an expert on internal or external groups to develop policies or guidance documents related to the product line. From time to time, serve as thought leader and provide expertise for research projects conducted by DCRI. Related to product line, develops educational materials, conducts educational programs, and provides mentorship for others, including internal staff and external groups such as pharmaceutical companies and other academic centers, non-statistical staff at the DCRI, and web-based seminars. Serves as a resource within the department on guidelines from the FDA, ICH, EMEA, IRBs, HIPAA, or other regulatory agency as they apply to statistics, programming, and handling of clinical data related to area of product focus. Shares solid understanding of clinical research and the clinical drug and/or device development process and maintains this evolving knowledge base into the future.
• Statistical Analysis and Contribution to Clinical Research Projects: 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. Develop strategy for data presentation and inference. Ensure 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:

• 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

Working Conditions:

This position is conducted in a professional office working environment or remotely. Occasional night or weekend work may be required depending on the demands of the given research task. This work may require some on site work at the DCRI for personnel management, sponsor engagements, and other duties best conducted in person.

Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy related conditions), sexual orientation or military status. Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values. Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.