Principal Statistical Programmer

IQVIA•Durham, NC

19h•Remote

About The Position

Principal Statistical Programmer, IQVIA RDS Inc. Durham, NC. May telecommute (work from home) from anywhere in U.S. and report to Durham, North Carolina location. Serve as subject matter expert on all aspects of SAS programming. Utilize understanding of pharmaceutical industry standards and trends and proactively plan, develop, and implement. Lead programming activities for multiple clinical studies across various phases (I-IV), ensuring timely and high-quality deliverables. Develop, validate, and maintain CDISC-compliant SDTM and ADaM datasets. Generate and validate Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions. 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. Provide programming support for PK/PD analyses, including data integration and visualization. Ensure adherence to CDISC standards, company SOPs, and regulatory guidelines (e.g., FDA, EMA). Regularly communicate with the sponsor on the progress of programming aspects of the project and proactively anticipate issues and work with the sponsor on resolution of the problems. Collaborate with Biostatisticians, Data Managers, and Clinical Teams to define programming requirements and specifications. Provide input and/or write the programming specifications. Participate in cross-functional initiatives to improve programming processes and tools. Maintain expertise in the use of SAS Macros and determine macro development priorities. Perform all responsibilities associated with the Senior Programmer role. Assist all the Sr. Programmers and Programmers in their day-to-day activities. Act as an escalation point for Sr. Programmer and Programmer. Mentor junior programmers and provide technical guidance and code reviews. Other responsibilities as defined on ad-hoc basis by senior management.

Requirements

Requires at least a Bachelor's degree in Computer Science, Mathematics, Statistics, or related field or foreign equivalent.
Requires five (5) years of experience in statistical programming in the pharmaceutical or medical devices industries to include 5 years: implementing all SOPs, Guidelines and Work Instructions; interpreting, modifying, and adapting company standards, project specifications, tasks, and goals; Pharmaceutical clinical development including understanding of safety deliverables and efficacy analysis supporting regulatory submissions; SAS, proc report, exposure to macros, current CDISC data structures, standardization methodology, and debug SAS programs; SAS Macro programming, SAS SQL, XML, RTF, and PDF; and four (4) years: Define.xml, Pinnacle 21, aDRG, and sDRG.

Responsibilities

Serve as subject matter expert on all aspects of SAS programming.
Utilize understanding of pharmaceutical industry standards and trends and proactively plan, develop, and implement.
Lead programming activities for multiple clinical studies across various phases (I-IV), ensuring timely and high-quality deliverables.
Develop, validate, and maintain CDISC-compliant SDTM and ADaM datasets.
Generate and validate Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions.
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.
Provide programming support for PK/PD analyses, including data integration and visualization.
Ensure adherence to CDISC standards, company SOPs, and regulatory guidelines (e.g., FDA, EMA).
Regularly communicate with the sponsor on the progress of programming aspects of the project and proactively anticipate issues and work with the sponsor on resolution of the problems.
Collaborate with Biostatisticians, Data Managers, and Clinical Teams to define programming requirements and specifications.
Provide input and/or write the programming specifications.
Participate in cross-functional initiatives to improve programming processes and tools.
Maintain expertise in the use of SAS Macros and determine macro development priorities.
Perform all responsibilities associated with the Senior Programmer role.
Assist all the Sr. Programmers and Programmers in their day-to-day activities.
Act as an escalation point for Sr. Programmer and Programmer.
Mentor junior programmers and provide technical guidance and code reviews.
Other responsibilities as defined on ad-hoc basis by senior management.