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Senior Statistical Programmer - FSP(m/w/x)
Leading pooled analyses and creating submission-ready ADaM datasets for regulatory submissions at a global healthcare data science firm. 5+ years of clinical programming experience with extensive SAS expertise required. Home-based remote work.
Anforderungen
- BSc in Computer Science, Mathematics, Statistics or related area
- At least 5 years of experience in clinical programming or statistical programming
- In-depth understanding of clinical programming and statistical programming processes
- In-depth understanding of regulatory requirements relevant to statistical programming
- Extensive experience with statistical programming using SAS software
- Strong programming and problem-solving skills
- Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)
- Proven experience in leading programming activities for clinical studies
- Ability to work effectively independently or in a team setting
- Experience in cross-functional, multicultural and international clinical trial teams
Aufgaben
- Review datasets in submission-ready standard format (ADaM)
- Create tables, figures, listings, and submission packages
- Collaborate with study teams to design data structures and specifications
- Ensure quality and accuracy of clinical data for submission readiness
- Lead pooled and exploratory analyses with Statistics TA lead and study statisticians
- Oversee in-house specification and delivery of ISS and ISE datasets
- Design and implement complex SAS programs for clinical trial data analysis
- Develop global tools to enhance efficiency in the Statistical Programming group
- Plan and execute activities with clinical study teams to meet project timelines
- Collaborate with CR&D staff on data analysis requests
- Perform additional statistical analyses to support regulatory agency responses
- Generate integrated summaries of safety and efficacy
- Support publications and presentations
- Conduct exploratory analyses for planning and reporting of clinical trials
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- SAS
Benefits
Flexibles Arbeiten
- Home-based remote work opportunities
Familienfreundlichkeit
- Great work/life balance
Lockere Unternehmenskultur
- Collaborative team environment
Sicherer Arbeitsplatz
- Job stability
Karriere- und Weiterentwicklung
- Career advancement opportunities
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- IQVIAVollzeitmit HomeofficeSeniorFrankfurt am Main
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Senior Statistical Programmer - FSP(m/w/x)
Leading pooled analyses and creating submission-ready ADaM datasets for regulatory submissions at a global healthcare data science firm. 5+ years of clinical programming experience with extensive SAS expertise required. Home-based remote work.
Anforderungen
- BSc in Computer Science, Mathematics, Statistics or related area
- At least 5 years of experience in clinical programming or statistical programming
- In-depth understanding of clinical programming and statistical programming processes
- In-depth understanding of regulatory requirements relevant to statistical programming
- Extensive experience with statistical programming using SAS software
- Strong programming and problem-solving skills
- Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)
- Proven experience in leading programming activities for clinical studies
- Ability to work effectively independently or in a team setting
- Experience in cross-functional, multicultural and international clinical trial teams
Aufgaben
- Review datasets in submission-ready standard format (ADaM)
- Create tables, figures, listings, and submission packages
- Collaborate with study teams to design data structures and specifications
- Ensure quality and accuracy of clinical data for submission readiness
- Lead pooled and exploratory analyses with Statistics TA lead and study statisticians
- Oversee in-house specification and delivery of ISS and ISE datasets
- Design and implement complex SAS programs for clinical trial data analysis
- Develop global tools to enhance efficiency in the Statistical Programming group
- Plan and execute activities with clinical study teams to meet project timelines
- Collaborate with CR&D staff on data analysis requests
- Perform additional statistical analyses to support regulatory agency responses
- Generate integrated summaries of safety and efficacy
- Support publications and presentations
- Conduct exploratory analyses for planning and reporting of clinical trials
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- SAS
Benefits
Flexibles Arbeiten
- Home-based remote work opportunities
Familienfreundlichkeit
- Great work/life balance
Lockere Unternehmenskultur
- Collaborative team environment
Sicherer Arbeitsplatz
- Job stability
Karriere- und Weiterentwicklung
- Career advancement opportunities
Über das Unternehmen
IQVIA
Branche
Healthcare
Beschreibung
IQVIA is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.
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