Director, Clinical Data Standards

BeiGene

Department: Biometrics

Reports to (Title): Head of Statistical Programming & Clinical Informatics

Type of Contributor (Individual or Manager): Manager

Position Summary Why does this position exist?

This position oversees the management and governance of end-to-end Data Standards and Clinical Programming at BeiGene. This position is responsible for the recruiting and training of resources, establishing and overseeing eCRF data standards, SDTM data mapping, clinical programming and visualizations, operating procedures, computing environment requirements, biometrics software integrations and best practices. The incumbent will also provide management oversight of computing environment deliverable timeline and quality in compliance with applicable department and regulatory requirements. The position reports directly to the Head of Statistical Programming and Clinical Informatics.

Essential Duties & Responsibilities What tasks are critical to job success?

  • Responsible for identification, establishment and maintenance of statistical computing environment, biometrics software and data collection and reporting standards.
  • Responsible for establishing and governance of BeiGene standard metadata repository and study level metadata repository for aligning programming processes using metadata.
  • Accountable for assessment, identification, development, implementation, validation, oversight and direction of statistical programming computing solutions including computing platform, system architecture, folder structure, metadata management, data warehousing, data access and other computing tools.
  • Collaborates with multiple functional areas across the company in strategic evaluation and assessment of informational and computational needs, solutions and key business development opportunities.
  • Accountable for identifying functional process needs, driving standardization, defining and implementing best practices for statistical programming and clinical programming solutions.
  • Accountable for internal and external audits on topics related to statistical programming and clinical computing group.
  • Responsible for identifying strategic needs in technical knowledge, provide training for the computing environment and driving the strategic technology direction for the group.
  • Interacts with internal and external collaborators in the development and dissemination of data and computing tools.

Core Competencies, Knowledge and Skill Requirements

  • PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
  • Ability to build and manage a
  • Strong understanding of computing system architecture, compliance requirements and implementation strategy.
  • Must have advanced skills in SAS programming language, especially macro facility, data step programming and report
  • Advanced knowledge of clinical systems, statistical computing solutions and processes for data share, analytics and governance.
  • In depth knowledge of requirements for electronic submission of standardized data as per regulatory requirements.
  • Able to multi-task, work collaboratively with the teams, while maintaining accuracy and attention to
  • Excellent problem solving skills

Communication & Interpersonal Skills (minimum standard language provided)

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

Significant Contacts (Specify internal and external interactions)

Interact and collaborate effectively with internal and external (e.g., CRO, software vendors) study management teams and other departments to meet project timelines and goals.

REQUIREMENTS

Education (Indicate if there’s a preferred degree or specified field of study)

B.S. degree in computer science, statistics, or related field required. Master’s degree in statistics or related field is preferred.

Experience

15+ years of SAS statistical programming experience in the biotech/pharmaceutical industry environment and 10+ years of supervisory experience.

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.
  • Travel 5-10%

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

Apply using webmail: Gmail / AOL / Yahoo / Outlook