Director Biostatistics, SARC / null

Organisatie: Covance Inc
Locatie: null
Functie: Director Biostatistics, SARC
Vervaldatum: 06/07/2021
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Job Overview:

  • Director Biostatistics, SARC required to work within Covance by Labcorp’s Statistical Analysis Research Centre
  • You will consult in the design of complex and innovative studies and clinical trial programs as well as Leading the DMC/DSMB processes
  • Previous experience of supporting data monitoring committees essential
  • This is a permanent full-time role, either office based, or home based anywhere in Europe
  • 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.

    Job Primary Functions

  • Represents the department in capabilities presentations in order to win all client relationships.
  • Participates in proposal development for mid-size programs and/or new drug applications (NDAs) and in bid defense
  • Oversee in the design and consultation and regulatory considerations on complex studies, and multi-protocol programs. Providing statistical oversight and attending relevant project meetings
  • Oversee all DMC processes; Serve as DMC Support Statistician, developing DMC Charters and attending DMC Meetings
  • Provide statistical guidance in the development of Clinical Development Plans as well as complex Statistical Analysis Plans; perform senior review of statistical analysis plans developed by other statisticians
  • Interact and contribute statistical support to Senior Leadership and company and department working groups
  • Present and/or chair/organize sessions at external conferences/groups and internal meetings; increase Covance visibility in scientific community (internal and external)
  • Monitors projects quality, timelines and budgets to foresee and correct issues and assure project expectations are met
  • Ensures that resources are utilized efficiently and utilization targets are met
  • 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 and mentoring to team members.
  • 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
  • Education/Qualifications:

  • Master’s degree, equivalent, or higher in Biostatistics or related field
  • 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
  • Ability to perform sample size determination using appropriate statistical software such as NCSS PASS, Cytel EAST, StatSols nQuery, or SAS
  • Exhibits knowledge of advanced biostatistical methodology
  • Experience of adaptive clinical trial designs
  • 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)

    Categorieën: Vacatures
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