Principal Statistical Programmer
About The Position
Plan and coordinate the development of integrated programming solutions, serving the full spectrum of statistical programming needs. Provide technical expertise to develop process methodology for department to meet internal and external clients’ needs. Regularly communicate with the sponsor on the progress of programming aspects of the project, proactively anticipate issues, and work with the sponsor on resolution of the problems. Provide technical expertise and leadership to the department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements. Provide input and/or write the programming specifications. Serve as subject matter expert on all aspects of SAS Programming. Understand pharmaceutical industry standards and trends and proactively plan, develop, and implement accordingly. Develop consistent practices of clinical and statistical review of output and mentor programming staff. Check for consistency across therapeutic areas. Identify, plan, and oversee the implementation and success measures of all process improvement initiatives. Maintain expertise in the use of the SAS Macros and determine macro development priorities. Assist all the Sr. Programmers and Programmers in their day-to-day activities. Act as escalation point for Sr. Programmers and Programmers.
Requirements
- At least a bachelor’s degree in statistics, pharmaceutical sciences, or related field or foreign equivalent.
- Five (5) years of statistical programming experience.
- Five (5) years of experience overseeing and guiding programming activities for regulatory submissions (including NDA or BLA).
- Five (5) years of experience ensuring compliance with global health authority requirements.
- Five (5) years of experience developing and implementing programming standards, SOPs, and best practices.
- Five (5) years of experience identifying and implementing tools or processes to enhance programming efficiency, quality or automation.
- Five (5) years of experience serving as a subject matter expert in CDISC standards, including SDTM and ADaM.
- Five (5) years of experience creating and reviewing mapping specifications.
- Five (5) years of experience preparing and validating submission deliverables such as define.xml, SDRG, and ADRG.
- Five (5) years of experience performing data integration and pooling analyses (including ISS or ISE).
- Four (4) years of mentoring and coaching junior programming staff.
Responsibilities
- Plan and coordinate the development of integrated programming solutions.
- Provide technical expertise to develop process methodology.
- Communicate with the sponsor on project progress and issues.
- Provide technical expertise and leadership to the department.
- Provide internal consulting services, including specifications and user needs analysis.
- Provide input and/or write programming specifications.
- Serve as subject matter expert on SAS Programming.
- Understand and implement pharmaceutical industry standards and trends.
- Develop consistent practices of clinical and statistical review of output.
- Mentor programming staff.
- Check for consistency across therapeutic areas.
- Identify, plan, and oversee the implementation of process improvement initiatives.
- Maintain expertise in SAS Macros and determine macro development priorities.
- Assist Sr. Programmers and Programmers in their day-to-day activities.
- Act as escalation point for Sr. Programmers and Programmers.
Benefits
- Health and welfare benefits
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What This Job Offers
Job Type
Full-time
Career Level
Principal
