Job Information
Mallinckrodt Pharmaceuticals Senior Statistical Programmer in Seattle, Washington
Job Title Senior Statistical Programmer Requisition JR000014027 Senior Statistical Programmer (Open) Location Field Based Location - USA082 Additional Locations Albany, NY, Boston, MA, Bridgewater, NJ, Harrisburg, PA, Jacksonville, FL, Philadelphia, PA, Raleigh, NC, Richmond, VA Job Description The Sr. Statistical Programmer is responsible for leading all SAS programming tasks required for clinical trial analysis and reporting, including generation of SDTM and ADaM datasets, creation and validation of tables, listings and figures for Clinical Study Reports and ad hoc programming requests. The Sr. Statistical Programmer provides expertise in SAS programming and related processes to the Biometrics group, including implementation of CDISC standards, as well as ICH and FDA guidance on data and reporting standards. This role may develop standard macros and/or tools for data analysis and reporting. Essential Functions: Manage or lead assignments on single or multiple projects Create SDTM mapping specifications and ADaM data specifications Generate and validate SAS data sets, tables, listings and figures per protocol and statistical analysis plan and for ad-hoc requests Create SDTM and ADaM define.xml files and associated Reviewer's Guides. Ensure adherence to company Standard Operating Procedures (SOPs) and relevant regulatory requirements for the development, usage, and maintenance of programs to support regulatory submissions Perform QC review on regulatory submission programs, datasets and documents Implement Global Programming Standards as available and perform statistical programming activities to achieve high quality and timely study deliverables that are consistent with expectations Assist in timelines set up and communicate to functional leadership on project status and resource issues Remain informed of new developments in relevant CDISC programming standards Represent statistical programming function in cross-functional study teams Train or mentor more junior level statistical programmers Minimum Requirements: Bachelors degree in Life Science, Computer Science, or related discipline; Masters preferred 6+ years of Clinical System Management, Database Programming, or SAS programming experience in Pharmaceutical or Biotech related environments. Experience leading SAS programming activities for clinical trials. Strong working knowledge of CDISC SDTM, ADaM and define.xml Proficient programming knowledge of BASE/SAS, SAS Macros, ODS and SAS/Graph in a Windows SAS environment Understanding of data and system dependencies, validation techniques and integration of studies for ISS/ISE Proficient in industry standards for clinical trial datasets and programming methodologies Competencies: Interpersonal Skill Converses with, and writes to, peers in ways that support transactional and administrative activities. Seeks and shares information and opinions. Explains the immediate context of the situation, asks questions with follow-ups, and solicits advice prior to acting. Data Integrity Proactively detects and corrects errors in data collection, designs standard modules for consistent assembly, and ensures data security through access monitoring. Demonstrates ownership of complex data outcomes for study-level analysis. Analytical Skills Analyzes data trends to troubleshoot and solve problems, independently identifies, and comprehends data trends, their causes, and their impact on decision-making, and independently plans and executes small-scale data analysis projects. Organizational Relationship/Scope: This position reports to the Manager Clinical & Statistical Programming and no direct reports. Will interact with different departments throughout the Clinic