Global Statistical Standards at Covance encompasses the development and use of CDISC standards within our organization; encourages and assists our clients in developing standards and standard’s strategies; provides consultation and data conversion services to clients conducting data submissions to regulatory groups; furthers the development of standards with organizations such as CDISC, FDA, and PhUSE; and educates industry of Covance’s end to end standards offerings.
In this role, the Sr. Director, Global Statistical Standards will participate in a variety of duties related to supervision of Biostatistics staff as well as overall leadership of the department; ensure departmental goals and deliverables are met; coordinate the development and review of regulatory submissions (e.g., NDAs). Keep department appraise with the latest CDISC standard and submission regulations in accordance with Covance and/or sponsor Standard Operating Procedures (SOPs) or study specific guidelines; responsible for revenue, forecasting and resourcing; and manage and/or mentor junior level staff.
Additional responsibilities include:
- Develop and maintain close working relationships with the management of other disciplines, particularly those that interact closely with the department, to ensure consistency in approach, ongoing cooperation and teamwork, and regular discussion regarding process improvements.
- Actively promote business development activities, marketing statistical and statistical programming capabilities so as to acquire new business within the strategic plan.
- Interact with senior leadership across disciplines at a global level.
- Support senior management in all aspects of the management and development of the discipline.
- Maintain a positive approach, building a motivating and professional team environment.
- Facilitate the flow of information, comment and feedback between senior management and all levels of staff.
- Build an open and communicative environment in which concerns can be raised and where the input of all is evidently valued.
- Work closely with Human Resources to devise recruitment strategies, perform recruitment activities on behalf of the department, and achieve a high retention rate.
- Work with Training specialists and other disciplines to ensure all members of the department receive training required to fulfill current role or to develop further.
- Provide ongoing guidance and mentoring within the department to ensure thorough knowledge of the processes used and ongoing technical development.
- Carry out line management responsibilities for assigned staff, including Performance Management and Development activities, disciplinary procedures and administrative activities.
- Provide input to the optimal global utilization of resources in Statistical Programming based on project requirements, resource availability, efficient utilization, and staff competencies and development needs.
- Work with global counterparts and senior management within other disciplines to optimize utilization of resource.
- Responsible for giving input to planning of, and for subsequent management of, departmental budgets to the maximum benefit of individuals, the department and the business.
- Ensure that appropriate project management tracking and review activities occur within the department on a regular and timely basis with resolution of identified issues and proactive tracking and financial management of non-contract tasks.
- Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management.
- Ensure provision of input and review of new business proposals, including time and cost estimates and associated documentation; participate in associated client development activities.
- Prioritize workload within the department to meet specified completion dates while maintaining high levels of quality, internal and external client satisfaction, and profitability.
- Ensure the delivery of high quality work to internal and external clients through ongoing quality management and review.
- Advise on statistical Programming aspects of submissions to regulatory authorities; participate in presentations to regulatory reviewers.
- Identify opportunities to interact with other operational areas to further the delivery of quality and timely products by Covance.
PhD/MS preferred, at least bachelor is required with a strong CDISC industry background.
- Fifteen years of relevant work experience with approximately 8 years of supervisory experience to include biometrics and/or statistical programming and at least 3 years of project responsibility with a CRO.
- Strong managerial and interpersonal skills.
- Demonstrated skill for management of staff exceeding 15 employees at a site.
- Financial management of gross revenues in excess of $3M .
- Excellent oral and written communication and presentation skills; able to communicate effectively throughout Covance and with its clients.
- In-depth knowledge of the clinical trial process, statistical programming, quality management, and systems applications to support operations.
- Knowledge of the metrics, tools and processes used within Covance to manage projects.
- Excellent problem-solving skills and ability to take ownership of decision-making.
- Demonstrates self-motivation to lead team on business strategies and achievement of department goals, objectives, and initiatives.
- A proactive approach to the management of day-to-day activities and actions that may affect Covance as a business.
- The ability to plan and to adapt to changing situations.
- Experience with Metadata Repository (MDR) systems