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Senior Statistical Programmer

Remote: 
Full Remote
Experience: 
Senior (5-10 years)
Work from: 
Connecticut (USA), Illinois (USA)

Offer summary

Qualifications:

8+ years of Statistical Programming experience in life sciences industry., Experience with SAS statistical software and CDISC (SDTM & ADaM)..

Key responsabilities:

  • Hands-on SAS Programming for clinical tables, listings, and graphs.
  • Validation and QC of programs, datasets, and statistical reports.
  • Authors SDTM and ADaM dataset specifications.
  • Deliver end-to-end programming from CRF design to ESUB components.
Katalyst HealthCares & Life Sciences logo
Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/
51 - 200 Employees
About Katalyst HealthCares & Life Sciences
Katalyst Healthcare's & Life Sciences (Katalyst HLS) is a Global Contract Research Organisation that provides End-to-End Clinical Research Services for Healthcare and Life Sciences companies globally. At Katalyst HLS offers ICH-GCP compliant clinical trial services from Phase I–IV in all key therapeutic areas to support clinical development and research requirements and also provides validation, quality and regulatory services for Pharma/Bio-Pharma/Medical Device industries. Services:- Clinical Trial Management- Clinical Data Management- Biostatistics & Statistical Programming- Medical Writing- Pharmacovigilance- Quality and Regulatory Affairs- GMP, GLP and GCP Validations- Manufacturing Process Validations- Equipments & Instruments Validations- Computer Systems Validations- Human Resourcing
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:
  • 8+ 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.

Required profile

Experience

Level of experience: Senior (5-10 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Clinical Data AnalysisRegulatory FilingsSAS MacrosCAD Standards
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