Senior Clinical Safety Programmer (Remote)

Kaztronix


Job Description
Senior Clinical Safety Programmer

Position Overview:
Lead Clinical Safety Programmer to join our Clinical Safety Statistics group to be located in Gaithersburg, MD or to be remote. The successful candidate will support statistical programming and related activities in Phase 1 to 4 clinical trials for aggregate, program-level safety assessments. This position will report to the Senior Director, Safety Statistics in Global Vaccine Safety. We will partner together with clinical safety professionals in Aggregate Safety Assessment Planning and Ongoing Aggregate Safety Evaluations.
Responsibilities include but are not limited to:
  • Support statistical programming and related activities in Phase 1 to 4 clinical trials for aggregate, program-level safety assessments.
  • Help develop global programming standards for aggregate safety analyses and reporting, especially for visual/graphical displays.
  • Create/validate integrated safety datasets and safety topics of interest according to the Aggregate Safety Assessment Planning process.
  • Develop/validate programming for tables, listings and figures in accordance with the Ongoing Aggregate Safety Evaluation plans.
  • Support safety programming activities for regulatory interactions and submissions, working closely with statisticians, programmers, and regulatory affairs representatives.
  • Collaborate with Biostatistics and Clinical Operations on scientific evaluation of integrated safety data (such as, the IB/RSI, DSUR, RMP, ISS, and CTD).
  • Provide input to general departmental processes and procedures; take part in or lead process initiatives as required by line manager.
Minimum Requirements:
  • BS degree in Statistics, Data Science, Computer Science, or related field.
  • Eight years SAS programming experience (Base SAS, SAS/STAT, and SAS macro language) on clinical trial data for pharma, biotech, or CRO companies.
  • At least 1 year of experience working on data collected from vaccine clinical trials.
  • Programming experience in producing output for periodical safety reports (such as for the SRT, DSMB, DSUR, or ClinicalTrials.Gov), or output to support publications.
  • Experience creating CDISC SDTM/ADAM domains from clinical trial data, including for electronic submission of SDTM/ADaM datasets.
  • Familiar with MedDRA coding, including SMQs and CMQs.
  • Experience using the SAS Output Delivery System to output tables, listings, and figures.
  • Good verbal and written communication skills, detail orientated, able to work comfortably with tight deadlines.
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