Department: Biometrics

Reports to: Director, Statistical Programming

Type of Contributor (Individual or Manager):Manager

Position Summary:

The Assoc. Director, 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)
• 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/CFDA trial and regulatory submissions
• Experience with the drug development process (pre-, early, late and/or observational) in related industries or academic research

REQUIREMENTS

Education:

• 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
• 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.