Senior Statistical Programmer

Location: Home-based in the U.S. or Canada

Summary: Make a significant impact on the study successes for a Pharmaceutical company. We have an established sponsor-dedicated team that works fully within the environment of the Pharma, progressing with in-house SAS programming activities over the years. IQVIA is hiring for a Senior Statistical Programmer to expand the long-term efforts of this team.

• Work collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
• Create and/or validate all safety and efficacy study output requirements (SDTM, ADaM, TLFs).
• Assesses the quality and consistency of analysis data and performs cross-study analyses.
• Use internal macros or writes SAS® macros to automate study deliverables.
• Work as a primary programmer for multiple Phase 1-4 studies.
• Assists in submissions of electronic data (e.g., SAS datasets) to regulatory agencies.
• Independently develops analysis specification & programs (following CDISC standards).
• Identifies potential issues in study documentation and proposes solutions.
• Assist with study and systems audits by GSI Compliance Group and external bodies, and respond to audit questions and findings.

Qualifications:

• Must be able to work independently on multiple clinical trial projects.
• Must have thorough knowledge of clinical trial study design and electronic data submission requirements to meet expectations of FDA or other regulatory agencies.
• 6 years of experience and a BS degree in Biostatistics, Computer Science or related.
• 4 years of experience and a MS degree in Biostatistics, Computer Science or related.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status