IQVIA · 2 days ago
Principal Statistical Programmer, RWE
Durham, NC
Full-time
Remote
Senior Level, Lead/Staff
$106K/yr - $218K/yr
8+ years exp
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Responsibilities
Supporting clients HEOR and Medical Affairs teams to develop and validate statistical programs for data analysis and compliance with industry standards.
Ensure all programming activities comply with CDISC standards (SDTM and ADaM) and regulatory guidelines (ICH E6, E3, E8, E9).
In addition to performing all senior statistical programmer duties, the Principal Statistical Programmer will also assist all the Sr. Programmers and Programmers in their day-to-day activities and act as escalation point for complex programming queries
Regularly communicates with the sponsor on the progress of programming aspects of the project and proactively anticipates issues and works with the sponsor on resolution of the problems
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
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
Utilizing R programming to assess and program EMR data via GitHub repositories set up by client
Qualification
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Required
Minimum 8 years’ SAS programming experience within Clinical Research Organization or sponsor environment supporting RWE teams, plus 3 years of recent lead experience required
Must have excellent knowledge of CDISC standards (SDTM and ADaM)
Must have expertise of SAS® Base, and good knowledge of SAS® graph and SAS® Macros.
Strong R programming ability required
Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician.
Thorough understanding of relational database components and theory.
Excellent application development skills.
Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis, and reporting of analysis results.
Good understanding of ICH E6, ICH E3, ICH E8, ICH E9, and clinical research processes.
Benefits
Home-based remote work opportunities
Great work/life balance
Collaborate on projects and innovations with industry leaders in the Pharma and CRO sectors
Cohesive team environment fostering a collaborative approach to study work
Variety of therapeutic areas, indications and, study phases
Job stability; long-term engagements and development opportunities
Career advancement opportunities
Company
IQVIA
IQVIA provides analytics, compliance, and management solutions to the life sciences industry.
10,001+ employees
H1B Sponsorship
IQVIA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (218)
2022 (199)
2021 (286)
2020 (197)
Funding
Current Stage
Public CompanyTotal Funding
$1.5B2023-11-14Post Ipo Debt· $500M
2023-05-18Post Ipo Debt· $1B
2019-08-08Post Ipo Equity· Undisclosed
Leadership Team
Chris Colapietro
Vice President, Customer Engagement
Christina Bodurow
Vice President, Global Regulatory Affairs
Recent News
2024-10-31
The Pharma Letter
2024-05-29
2024-05-05
Company data provided by crunchbase
