Department: Statistical Programming
Reports to (Title): Director, Statistical Programming
Type of Contributor (Individual or Manager): Manager
Position Summary Why does this position exist?
The Statistical Programming Manager will work in BeiGene’s Statistical Programming group. The position is an individual contributor role and will primarily involve project management of clinical studies in Phase I-IV.
Essential Duties & Responsibilities What tasks are critical to job success?
If position is a Supervising Manager add managerial responsibility (standard language provided in red)
- Manage and lead validation team for SDTM mapping for all clinical
- Follow CDSIC Implementation Guide to review and confirm dataset specifications and eCRF annotations for creation of SDTM
- Work with SDTM production team to address mapping and validation
- Work in cross-functional team to standardize eCRFs and Controlled
- Work with project lead to improve SDTM mapping process, develop macros for efficient coding and keep up with CDISC
- Manage and oversee multiple contractors in India and onsite to oversee training, hiring, mentoring and resourcing for SDTM
- Interact and communicate with Statisticians, Data Managers and Study Teams to address deliverables, timelines and project
- Develop validation SAS programs to produce SDTM datasets for verification
- Understand and execute department-, product- and study-level macros and
- Develop, test and validate new macros and
- Provide input to and participate in intra-departmental
- Contribute to the continuous improvement of Statistical programming
- 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
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
- Computer programming using SAS
- Understanding of computer operating systems, word processors, document applications
- Fundamentals of project planning and management
- Drug Development (pre-, early, late and/or observational) in related industries or academic research
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)
Interacts with all levels of BeiGene personnel
DESIRED BACKGROUND AND EXPERIENCE (Include License or Certifications)
- Expert level SAS programmer with experience in delivering on complex programming assignments and analysis
- Extensive hands-on experience in CDSIC standards and datasets (SDTM, ADaM)
- Oncology Trials
- FDA/EM EA Trial and regulatory submissions
Education (Indicate if there’s a preferred degree or specified field of study)
Bachelors or Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject
5+ years of experience in biotech/pharmaceutical or related area;
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.
- Include travel requirements, if applicable