Clinical Application Specialist III

1 week ago

Lake Bluff, IL, United States Katalyst Healthcares and Life Sciences Full time
Job description:
  • Describe the primary goals, objectives or functions or outputs of this position.
  • This role is responsible for leading the statistical programming activities for development and maintenance of integrated clinical safety data sets for one or more compounds/indications or therapeutic areas. This role must effectively interface with team members from Statistics, Data Sciences, Pharmacovigilance and Patient Safety, Data Analytics, Medical Writing, Regulatory Publishing and Clinical Operations.
Responsibilities:
  • In depth knowledge on CDISC Standards, SAS programming concepts and techniques appropriate to the pharmaceutical industry.
  • Experience in leading compound level data integration efforts to create pooled ADAM datasets by pooling data from multiple studies, completed and ongoing, across indications.
  • Experience in ADaM specs and SAS programs development supporting ISS/Client ADaM programming and submissions.
  • Oversee and responsible for the creation and validation of SDTM, ADaM and TLFs for CSR, ISS, and Client following Client's SOPs, department, and project standards.
  • Experience in supporting IB, DSUR and Annual Safety Reporting deliverables.
  • bility to quickly learn internal macros, processes and programming environment.
  • Team player with excellent communication skills and experience working with stat programmers, statisticians, data management personnel and Pharmacovigilance stakeholders.
  • Oversee and responsible for the creation and accuracy of derivations as defined in the protocol and statistical analysis plan.
  • Ensure internal consistency of output and assess consistency with other activities for the project (Pooled data vs. ISS, Study data), as applicable.
  • Demonstrated satisfactory ability to interpret statistical analysis plans to develop analysis data set specifications.
  • Ensure all Client's process improvements are implemented.
  • Provide accurate and timely responses to requests from clients with a sense of urgency.
  • Be compliant with training requirements.
Requirements:
  • BS or MS in Statistics, Computer Science or a related field with at least 8 years of SAS programming experience in Pharmaceutical or related industry.
  • Extensive experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA.
  • Excellent working experience/skill in SDTM and ADaM datasets creation/validation.
  • High degree of technical competence and excellent communication skills, both oral and written.
  • Demonstrated competency and hands-on experience in SAS programming, macro and utilities development.
Top Skills:
  • SAS Programming.
  • SDTM and ADaM programming and developing specifications.
  • Supported/Led IB, DSUR, PSUR, ISS, Client, Study CSR work.
  • Solid understanding and experience with CDISC data standards.
  • Good communication skills and team player.

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