Department: Biostats/Statistical Programming
Reports to: Director, Statistical Programming
Type of Contributor: Manager
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
- Bachelors or Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject, or equivalent related 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:
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.