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- Senior / Principal Statistical Programmer (m/w/d)
Senior / Principal Statistical Programmer (m/w/d)
IQVIA Holdings Inc.
Primary Location: Amsterdam, Netherlands
Additonal Locations: Budapest, Hungary,HUN; Centurion, South Africa,ZAF; Frankfurt, Germany,DEU; Nairobi, Kenya,KEN; Reading, United Kingdom,GBR; Warsaw, Poland,POL; Zaventem, Belgium,BEL
IQVIA has built a highly skilled biometrics team, dedicated to the internal study activities for a prominent Pharma company. We are now expanding this team and hiring for a Senior Statistical Programmer. Be highly involved in sponsor-side programming activities with SDTM and ADaM datasets, safety & efficacy domains, pooling of studies (ISS/ISE) and submission deliverables. Work across multiple Therapeutic areas including Rare Disease, Virology, Oncology or Hematology. Expect to work fully within the sponsor's programming environment in this long-term, dedicated team.
Job duties:
Development of study outputs including SDTM/ADaM datasets, tables, listings, figures and QC of requested output.
Participate in the design, development and quality control process for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses.
Interact with internal departments of the sponsor - Biostatistics, Data Management, Regulatory Operations and Medical Writing.
Collaborates with peers and statisticians to ensure the submission readiness of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml).
Involvement with creation and maintaining programming specifications for SDTM, ADaM and integration of data in support of ISS/ISE.
Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group.
Perform additional statistical analyses including but not limited to: support responses to regulatory agencies; generate integrated summary of safety and efficacy; support publications and presentations; support planning and reporting of clinical trials via exploratory analyses of available data; replicate vendor and statistician analyses for QC.
Our expectations of you:
5 years or more in SAS programming for clinical trial data.
Bachelor’s degree in Math, Stats, Computer Science, Pharmacy, Biology or related.
Strong knowledge in CDISC standards (SDTM, ADaM).
Knowledge in the creation of define.xml, Pinnacle 21, aDRG, and sDRG.
Knowledge of pharmaceutical clinical development - understanding of safety deliverables and efficacy analysis supporting regulatory submissions.
Knowledge of base SAS, proc report, exposure to macros, current CDISC data structures, and standardization methodology; demonstrated ability to debug SAS programs.
High degree of technical competence in SAS Macro programming, SAS SQL, XML, RTF, and PDF.
Demonstrated teamwork, pride of ownership, accountability, problem-solving and innovative skills.
Job posted: 2023-11-13