The 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
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
The Manager, Statistical Programming will work in BeiGene's Statistical Programming group. This position is based at BeiGene's San Francisco location.
5+ years of experience as SAS programmer with experience in delivering on complex programming assignments and analysis
Extensive hands-on experience in CDSIC standards and datasets (SDTM, ADaM)
FDA/EM EA Trial and regulatory submissions
Licenses or Certifications:
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.