Duke University
Associate Director

(Statistical Operations, DCRI Statistics)

Requisition # 400292200

Occupational Summary

Work closely with Director of Statistical Operations to assist in leadership and administrative responsibilities within the Clinical Trials Statistics Group. Manages a subset of staff (10-15 gradually over time) that is primarily focused on clinical trials statistics. Collaborates with the Associate Director, Statistical Group for Manuscript Analysis, to effectively manage and evaluate statisticians that share responsibility for both trials and secondary manuscripts. Participates in DCRI-wide initiatives and meetings and external sponsor meetings. Assumes responsibilities of the Director of Statistical Operations and the Administrative and Budgeting Coordinator when either individual is out of the office. Takes a leading role in developing and maintaining standard operating procedures. Mentors and trains non-faculty statisticians. Collaborates closely with the Administrative and Budgeting Coordinator when needed to assist in proposal development, project budgeting, and forecasting. Serves as an expert resource to all staff in addressing difficult and non-typical trial and analytic issues.

Work Performed

Operations Management (40%)

• Manages a subset of staff statisticians (10-15 individuals gradually over time) that are primarily focused on clinical trials statistics

• Monitors progress and performance of clinical projects being led by direct reports on an ongoing basis and ensure that services performed are in compliance with quality standards and within budgetary limits; ensures that delays are identified and brought to the attention of the Director of Statistical Operations, and that appropriate interventions are implemented to meet timelines

• Mentors direct reports on issues relating to clinical trials operations and statistics, as appropriate given the capabilities of the employee

• Leads the development and maintenance of standard operating procedures for group, such that workflow and operational processes maximize standardization of approaches across all projects for optimal efficiency, with oversight from Director of Statistical Operations

• Identifies operational problems, issues, obstacles, and barriers across projects; identifies trends and makes recommendations for improvement

• Develop and maintain a system for institutionalizing internal knowledge within the statistics group; gathers contributions from various staff statisticians holding key expertise

• Develop and maintain training materials for new statisticians

• Participates in DCRI-wide initiatives and meetings

• Understands and proactively remains abreast of guidelines from the FDA, ICH, EMEA, IRB, HIPAA, or other regulatory agency as they apply to statistics, programming, and handling of clinical data

• Demonstrates a solid understanding of the clinical drug and/or device development process

• Assumes responsibilities of the Director of Statistical Operations and the Administrative and Budgeting Coordinator when either individual is out of the office

Statistical Analysis and Contribution to Multi-Center Clinical Trials and/or Clinical Research Projects (30%)

• Serves consistently at the level of Senior or Principal Statistician with regard to statistical analysis and participation in multi-center clinical trials and projects

• Is sought after as a key project participant

• Retains primary responsibility of own analyses and clinical trials/projects in order to stay in touch with new experiences encountered by staff

Personnel Management (10%)

• Participates in the recruitment and hiring process, including screening of candidates, interviewing, and representing the group at recruitment functions

• Handles coaching and disciplinary actions, promotions, and transfers for direct reports

• Collaborates with Director of Statistical Operations and other Associate Directors to ensure consistent employee expectations and treatment across managers within the Statistics Department

• Gathers feedback from the Associate Director of Statistical Group for Manuscript Analysis to consistently manage and evaluate statisticians that share responsibility for both trials and secondary manuscripts

• Develops, implements, and conducts orientation programs for new employees

• Contributes to development of career paths and ongoing training and education of all Statistics staff

• Manages staff performance of direct reports: performance plans, coaching and feedback, performance evaluations, and development plans

• Reinforce and enforce goals, policies, procedures, and priorities to direct reports

• Develop and 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 (10%)

• Provides consultation and assistance to the Director of Statistical Operations and Administrative and Budgeting Coordinator as needed to assist in recruitment and budgeting of new DCRI trial/projects

• Represents the Statistics functional group in internal and external business development meetings, including presentations about the capabilities and operations of the Statistics group, for external clients in the pharmaceutical, medical device, biotechnology, or regulatory community

• Provide input into marketing materials (slide presentations, brochures) regarding statistical capabilities and services

Strategic Development (10%)

• Provides consultation and assistance to the functional group director in developing goals and objectives on an annual basis, and ensure alignment with the mission, vision, and goals of the DCRI; assist in developing strategic plans for the future direction of the functional group to ensure DCRI’s continued position as a leading ARO

• Keeps abreast with emerging developments and trends in the field of clinical biostatistics

• 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.

EDUCATION, EXPERIENCE, AND SKILLS

Position requires a minimum of a Master’s or Doctoral degree in (bio)statistics or related field and at least 8 (preferably 10 or more) years experience as a statistician in clinical research, including at least 5 years of experience working as a Senior Statistician and/or Principal Statistician or equivalent role, with progressively more responsible positions in academia and/or the pharmaceutical, medical device, or biotechnology industries. Candidates with a Bachelor’s degree in (bio)statistics or related field and a minimum of 10-12 years of highly relevant experience will be considered. Required knowledge, skills, and abilities include:

• Excellent interpersonal, communication, and presentation skills

• Calm and level-headed demeanor during times of tension

• Flexible, collaborative, and respectful management style

• Advanced statistical knowledge and analytical skills

• Excellent organizational skills, demonstrated ability to lead in a team environment, and an ability to supervise and delegate tasks

• Excellent working knowledge of clinical issues as they pertain to statistical analyses

• Experience working across a diverse range of clinical projects

REPORTING RELATIONSHIP

Reports to the Director of Statistical Operations (Functional Group Leader, Statistics) at the DCRI

Please email your resume and cover letter referencing the above job number and title to ylanier@duke.edu or apply directly to Requisition # 400292200 at http://www.hr.duke.edu/jobs/main.html