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Senior Statistical Programmer

Remote:

Full Remote

Experience:

Expert & Leadership (>10 years)

Work from:

United States

Offer summary

Qualifications:

10+ years of statistical programming experience in life science industry with BS degree, Experience with SAS statistical software and CDISC standards.

Key responsabilities:

Hands-on SAS programming for clinical Tables, Listings and Graphs
Validation of programs, datasets and statistical reports per study requirements
End-to-end programming of deliverables from CRF design to Electronic Submissions components

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:

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 SDTM and 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.

Requirements:

10+ years of Statistical Programming experience within the life science industry, preferably on the Sponsor side and relevant BS degree.
Experience with small to mid-size companies is preferable.
Must have experience performing data manipulation, analysis and reporting of clinical trial data specifically for both safety and efficacy (ISS/Client).
Experience producing TLFs, outputs, reports and QCing outputs effectively.
Expertise with SAS statistical software.
Strong knowledge of CDISC (must be skilled with both SDTM & ADaM).
Experience supporting regulatory submissions and submissions requirements, relevant ICH and FDA/EMEA/ROW guidelines.
Experience and understanding of drug development process and clinical trial.