Senior Statistical Programmer - FSP
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SeniorFull-time
#445498·Dodano 7 dni temu·1
Źródło: IQVIATech Stack / Keywords
SASSAS MacrosR ProgrammingCDISCCDASHSDTMADaM
Firma i stanowisko
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
Wymagania
- BSc in Computer Science, Mathematics, Statistics or related field with relevant experience.
- At least 5+ years of experience in clinical or statistical programming within CRO/pharmaceutical environments.
- In-depth understanding of clinical/statistical programming processes and standards.
- Extensive experience with SAS, including development and use of Macros.
- Hands-on experience in R Programming is mandatory.
- Advanced knowledge of CDISC standards (CDASH, SDTM, ADaM).
- Proven experience leading programming for pooled and exploratory analyses across multiple clinical studies.
- Ability to work independently and in team settings, managing own timelines.
- Experience working in cross-functional, multicultural, international clinical trial teams.
Obowiązki
- Collaborate with study teams to design data structures and specifications for ADaM datasets, tables, figures, listings, and analysis submission content.
- Ensure quality and accuracy of clinical data for regulatory submission (SDTM, ADaM, define.xml).
- Lead efforts for pooled and exploratory analyses with statisticians and clinical programming teams.
- Oversee specification and delivery of ISS and ISE datasets and associated outputs when not provided by CRO.
- Design and implement complex SAS programs for analyzing clinical trial data in CDISC ADaM format.
- Develop global tools to increase Statistical Programming group efficiency and capacity.
- Plan and execute project activities to meet timelines with high-quality deliverables.
Additional tasks:
- Collaborate with CR&D staff on data analysis requests.
- Perform statistical analyses supporting regulatory responses, integrated summaries, publications, presentations, and clinical trial planning via exploratory analyses.
Inne informacje
IQVIA maintains a zero-tolerance policy for candidate fraud. False statements, misrepresentations, or material omissions during recruitment result in disqualification or employment termination per applicable law.
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