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Senior Manager, Statistical Programming (FSP): Remote

Company: Covance
Location: Boston
Posted on: June 12, 2021

Job Description:

Job Overview:

Hiring for Senior Manager, Statistical Programming (Remote) FSP: can be based anywhere in USA/ Canada #LI-REMOTE

  • Participates in proposal development for standalone, small 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.
  • Manages discretionary expenses and spending within team in order to meet budget
  • Work closely with leads to ensure that staff resources are used efficiently, and team is well utilized
  • Manages resources within team: new hires, terminations, transfers, and contractors.
  • Carry out line management responsibilities for assigned staff, including Performance
  • Management and Development activities, disciplinary procedures and administrative activities.
  • Encourages staff career growth and development.
  • Provides statistical programming support and technical support to team members
  • Act as Statistical Programming Project Manager for large global or other major programs which may include global responsibilities.
  • Participates in internal and client audits, and regulatory inspections.
  • Proactively lead, review and amend departmental processes and documentation.
  • Facilitate advanced technical expertise, share knowledge at department meetings.
  • Keeps abreast of new statistical programming practices, methods and tools, regulatory practices, and industry trends to stimulate departmental growth

Education/Qualifications:

Minimum required:

  • BSc, preferably in computing, life science, mathematical or statistical subject

Experience:

Minimum Required:

  • Minimum 10+ years of experience, or an equivalent combination of education or experience to successfully perform the key responsibilities of the job.
  • Extensive experience leading statistical programming activities in clinical research. Previous experience in a

pharmaceutical research or CRO setting required.

  • Extensive experience and proven skills in the use of SAS programs within a clinical trials environment including all processes/practices used with a Statistical Programming environment.
  • Substantial knowledge of all aspects of clinical trials from initial study set-up to study completion. Complete knowledge and understanding of the processes and procedures used within a Statistical Programming environment and the ability to communicate to programmers and non-programmers alike.
  • Strong supervisory skills, and ability to organize their own and others' work.
  • Excellent problem solving skills, and a willingness to take ownership of decision-making.
  • Interpersonal and effective communication skills; able to communicate appropriately throughout Covance by Labcorp and with its clients.
  • Good knowledge of the metrics, tools and processes used within Covance by Labcorp to manage projects. Demonstrates good knowledge of clinical research guidance, including Food and Drug Administration (FDA), international regulatory agencies, international conference on harmonization (ICH), and good clinical practice (GCP).

Keywords: Covance, Boston , Senior Manager, Statistical Programming (FSP): Remote, Other , Boston, Massachusetts

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