Senior Manager, Statistical Programming

BeiGene

Department: Biostats/Statistical Programming

Reports to: Director, Statistical Programming

Type of Contributor: Manager

Position Summary:

The Senior Manager, Statistical Programming will work in BeiGene’s Statistical Programming group to manage and support Statistical Programming deliverables for multiple clinical studies.

Essential Duties & Responsibilities:

  • Technical lead and project manager for multiple studies managing all aspects of study deliverables related to statistical and clinical programming as needed
  • Represent the statistical programming team at Study Management Team and Clinical Development meetings to address deliverables and timelines
  • Address resourcing to adequately staff projects as needed
  • Assist in the review of key study-related documents produced by other functions, e.g. SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans and other clinical documents
  • Interact and communicate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing and Medical Monitors to address programming related study deliverables
  • Write, test and validate SAS programs to produce analysis datasets, TLGs and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications as needed
  • Understand and execute department-, product- and study-level macros and utilities. Write, test and validate product- and study-level macros and utilities
  • Be a technical resource for programming group to provide advice on complex programming tasks and/or standards.
  • Contribute to the development review of Statistical Programming policies, standard operating procedures and other controlled documents
  • Interface with outsourcing partners and vendor
  • Provide managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance
  • Other duties as assigned

Core Competencies, Knowledge and Skill Requirements:

  • Knowledge of SDTM and ADaM standards, able to write CDSIC standard dataset specifications and follow specifications to create SDTM and ADAM datasets (as needed)
  • PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
  • Computer programming using SAS
  • Fundamentals of project planning and management
  • Drug development process

Communication & Interpersonal Skills:

  • Excellent verbal and written communication skills
  • Ability to effectively collaborate in a dynamic environment

DESIRED BACKGROUND AND EXPERIENCE (Include License or Certifications)

  • Experience leading or working with centralized teams for Statistical Programming
  • Expert level knowledge and extensive hands-on experience of CDISC methodologies
  • Expert level SAS programmer with experience in delivering on complex programming assignments and analysis
  • Experience in Oncology Trials
  • Experience in FDA/EMEA trial and regulatory submissions
  • Experience with the drug development process (pre-, early, late and/or observational) in related industries or academic research

REQUIREMENTS

Education:

  • Bachelors or Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject, or equivalent related experience

Experience:

  • 10+ years’ clinical research and development programming experience using SAS with a related B.S., 6+ with a M.S. and 3+ with a PhD.
  • 4+ years of management experience

Licenses or Certifications:

N/A

TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT (AS APPROPRIATE FOR THE POSITION)

  • Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)
  • Ability to work on a computer for extended periods of time.
  • Regularly required to sit for long periods of time, and occasionally stand and walk.
  • Regularly required to use hands to operate computer and other office equipment.
  • Close vision required for computer usage.
  • Occasionally required to stoop, kneel, climb and lift up to 20 pounds.

To apply for this job email your details to us.careers@beigene.com

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