Katalyst CRO

Principal Statistical Programmer

5 months ago

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Responsibilities

Responsible for leading study team through end-to-end regulatory submission activities.
Hands-on SAS programming for creation and QC of clinical Tables, Listings and Graphs.
Perform validation and QC of the programs, datasets, and statistical reports per study requirements.
Authors ADaM dataset specifications including the identification of potential data issues or areas of critical data examination.
Deliver end-to-end programming of deliverables from CRF design through Electronic Submissions (ESUB) components.
Other related programming activities.
Will manage FSP programmers on assigned project, assigning workload, managing productivity and providing performance feedback as needed.
Participate in hiring and onboarding of operational FSP programmers.

Requirements

5+ years of Statistical SAS Programming experience within the life science industry, preferably on the Sponsor side.
Must have recent experience as the lead programmer for a regulatory submission, leading statistical programming efforts and activities.
Must have management experience including oversight, work assignment and productivity management of other programmers.
Needs to understand complex studies and have end-to-end regulatory submissions experience.
Safety and efficacy experience (ISS/Client) is required.
Must have experience performing data manipulation, analysis and reporting of clinical trial data.
Strong knowledge of CDISC (must be skilled with ADaM and SDTM).
Experience supporting regulatory submissions and submissions requirements, relevant ICH and FDA/EMEA/ROW guidelines.