1 day ago

Senior Statistical Programmer (FSP - Permanent Homebased)

IQVIA

Amsterdam

1 day ago

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Senior Statistical Programmer needed for a home-based FSP role with IQVIA. Requires 5+ years of SAS programming experience in clinical trials and expertise in CDISC standards. Responsible for leading programming activities and ensuring submission-ready datasets.

RemoteFull-timeSeniorSASSAS Macros

Senior Statistical Programmer (FSP - Permanent Homebased)

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RemoteFull-timeSeniorSAS

Salary

Not specified

Work Location

Amsterdam, North Holland, Netherlands, NL

Work Model

Remote

Experience Required

5 years

Employment Type

Full-time

Experience Level

Senior

Core Qualifications

Technical (Must-have)

SASSAS MacrosCDISCADaMSDTMCDASHRStatistical ProgrammingClinical ProgrammingDefine.xmlTablesFiguresListingsSubmission PackagesISSISE

Soft Skills

CollaborationProblem-solvingLeadershipTime ManagementTeamworkIndependenceCross-functional Communication

Key Responsibilities

•Collaborate with study teams to design data structure and specifications for ad hoc and study deliverables including ADaM datasets, Tables, Figures, Listings and Analysis Submission content.
•Ensure quality and accuracy of clinical data as required by authorities (SDTM, ADaM, tables, figures, listings, define.xml).
•Lead and oversee pooled and exploratory analyses working with Statistics TA lead and study statisticians.
•Lead and oversee in-house specification and delivery of ISS and ISE datasets and associated output.
•Lead and oversee design and implementation of complex SAS programs for analyzing and reporting clinical trial data in CDISC ADaM format.
•Lead and oversee development of global tools to increase efficiency and capacity of Statistical Programming group.
•Work with clinical study teams to plan and execute activities to ensure project timelines are met.
•Collaborate with CR&D staff regarding data analysis requests.
•Perform additional statistical analyses including support responses to regulatory agencies, generate integrated summary of safety and efficacy, support publications and presentations, and support planning and reporting of clinical trials.

Senior Statistical ProgrammerSASCDISCClinical TrialsPharmaceuticalCROFSPRemoteFull-timeNetherlands

Key Responsibilities

•Collaborate with study teams to design data structure and specifications for ad hoc and study deliverables including ADaM datasets, Tables, Figures, Listings and Analysis Submission content.

•Ensure quality and accuracy of clinical data as required by authorities (SDTM, ADaM, tables, figures, listings, define.xml).

•Lead and oversee pooled and exploratory analyses working with Statistics TA lead and study statisticians.

•Lead and oversee in-house specification and delivery of ISS and ISE datasets and associated output.

•Lead and oversee design and implementation of complex SAS programs for analyzing and reporting clinical trial data in CDISC ADaM format.

•Lead and oversee development of global tools to increase efficiency and capacity of Statistical Programming group.

•Work with clinical study teams to plan and execute activities to ensure project timelines are met.

•Collaborate with CR&D staff regarding data analysis requests.

•Perform additional statistical analyses including support responses to regulatory agencies, generate integrated summary of safety and efficacy, support publications and presentations, and support planning and reporting of clinical trials.