Director Biostatistics, FSP (Remote)
These permanent, remote opportunities can be worked from anywhere in the U.S. or Canada. #LI-REMOTE
Are you ready to discover your extraordinary potential at Covance by Labcorp? A career here provides the unique chance to create a lasting impact and difference in patients' lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy, innovative & collaborative work place, along with access to comprehensive benefits. Your work is meaningful, and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning. Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move.
We are seeking a Director of Biostatistics to consult on innovative and adaptive clinical trial designs, provide support for DMC/DSMB data review meetings, and analyze all parts of any clinical study. The selected candidate will provide statistical input into other disciplines' activities and participate in interdepartmental processes; provide technical solutions and advice to staff and clients on statistical processes; train less experienced biostatisticians within project activities; and be responsible for the development of Statistical Sections of Protocol including statistical methodology, statistical programming procedures, definition of derived variables, and data handling rules and data display templates.
Additional responsibilities include:
- Represents the department in capabilities presentations in order to win medium client relationships
- Participates in proposal development for mid-size programs and/or new drug applications (NDAs) and in bid defense.
- Monitors staff projects quality, timelines and budgets to foresee and correct issues and assure project expectations are met.
- Monitors discretionary spending in team to ensure that spending is within budget. Also provides input to budget setting.
- Ensures that resources within team are utilized efficiently and utilization targets are met.
- Manage resources within team ensuring that the team is of the right size through hiring, terminations, transfers and contracting.
- Carry out line management responsibilities for assigned staff, including Performance Management and Development activities, disciplinary procedures and administrative activities.
- Responsible for staff career growth and development.
- Provides statistical and technical support to team members.
- May act as the primary leader within one country or many countries.
- Develop and maintain close working relationships with the management of other disciplines, particularly those that interact with the department
- Participates in internal and client audits, and regulatory inspections.
- Represents the department on company process improvement initiatives.
- Establish, maintain, and strengthen a professional working relationship with clients, potential clients, regulatory agencies, collaborating staff, vendor, and subcontract personnel. Including serving on client operational committees.
- Organize team meetings to keep employees informed of new developments and to strengthen team spirit.
- Master's degree, equivalent, or higher in Biostatistics or related field
- Minimum 15 + years of experience, or an equivalent combination of education or experience to successfully perform the key responsibilities of the job, preferably with at least 5 years of line management experience.
- Strong managerial and interpersonal skills.
- Excellent problem solving skills, and a willingness to take ownership of decision-making.
- Excellent oral and written communication and presentation skills; able to communicate appropriately throughout Covance by Labcorp and with its clients.
- In-depth knowledge of clinical trial processes and biostatistics, and knowledge of statistical
- programming, data management, clinical operations, quality management, and systems applications to support operations.
- Exhibits knowledge of advanced biostatistical methodology.
- Demonstrates strong knowledge of clinical research guidance, including Food and Drug Administration (FDA), international regulatory agencies, international conference on harmonization (ICH), and good clinical practice (GCP).
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