Senior Manager, Statistical Programming

Beigene, Ltd. Emeryville , CA 94608

Posted 3 weeks ago

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)

  • Expert level SAS programmer with experience in delivering on complex programming assignments and analysis

  • Expert level knowledge and extensive hands-on experience of CDISC methodologies

  • Experience leading or working with centralized teams for Statistical Programming

  • 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

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

Ll- KC1


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VIEW JOBS 9/4/2019 12:00:00 AM 2019-12-03T00:00 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) * Expert level SAS programmer with experience in delivering on complex programming assignments and analysis * Expert level knowledge and extensive hands-on experience of CDISC methodologies * Experience leading or working with centralized teams for Statistical Programming * 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 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. #LI-KC1 Beigene, Ltd. Emeryville CA

Senior Manager, Statistical Programming

Beigene, Ltd.