Principal Statistical Programmer

Website CR Medicon

 

CR Medicon is a clinical development CRO dedicated to providing high-quality services including regulatory affairs, medical affairs, clinical operation, data management, statistical analysis, programming, and biological sample analysis. We are the most trusted and fastest-growing clinical trial service provider/partner for both domestic and overseas sponsors.

 

Principal Statistical Programmer

Department: Statistical Programming

Job Responsibilities:

  • Perform SAS data processes and analysis programming.
  • Works with Statistician and Statistical programmer to assure results are consistent with expectations, and Quality control procedures are followed.
  • Lead the development and delivery of training.
  • Act as primary contact to ensure that company standards are implemented in all studies.
  • Works collaboratively to meet study deliverables and timelines for statistical data analysis and reporting.
  • Plans and carefully documents differences between programming results between program developer and Statistical QC programmer.
  • Provided programming support on ISS/ISE and post-submission activities.
  • Provide flexible and rapid response to programming requests.
  • Ensure the consistency and adherence to standards within the project.
  • Confirms that tracking sheets are current for projects, and confirm that results are consistent with earlier generated results.
  • Maintain up-to-date study documentations.
  • Identify opportunities to improve the methodology and provide practical solutions for problems.
  • Develop, program, test and maintain computer validation/edit checks in SAS.
  • Validate peer programming.
  • Provide technical expertise and support to Data Management team.
  • Routinely interface with cross-functional team members.
  • Participate in regular team meetings and provide input when appropriate.
  • Participate in the development of clinical programming SOPs and the development/optimization of clinical programming processes from study start up to database lock.
  • Managing project priorities and timelines.
  • Have good knowledge of statistical terminology, clinical data structure, clinical tests, medical terminology, regulatory standards and protocol designs.
  • Review programming activities and costs in contracts.
  • Direct responsibility for supervising and training junior clinical programmers in the performance of their duties.

Qualifications:

  • BS degree or higher in programming or statistics.
  • SAS Experience in Pharmaceutical or equivalent: >=5 years Oncology experience preferred.
  • Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research.
  • Knowledge of CDISC standards and industry best practices.
  • Have good knowledge of statistical terminology, clinical data structure, clinical tests, medical terminology, regulatory standards and protocol designs.
  • Strong SAS programming / Macros development / SAS graphs skills.
  • Excellent oral and written skills for cross-site and cross-function collaboration.
  • Dependable, motivated, focused and detail orientated.
  • Ability to take direction as needed and work independently on project when necessary.
  • Capable of managing time effectively and adhering to timelines and project schedule Complementary Skills.
  • Working knowledge of SAS modules and utilities.
  • Ability to develop routines using the SAS Macro Language.
  • Strong SAS programming / Macros development / SAS graphs skills.
  • Understanding of biotech industry regulatory requirements.
  • Ability to use Microsoft Office tools: Word, Excel, PPT, etc.

If you are interested in this position, please contact Jenny Zhang jenny.zhang@crmedicon.com.