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Statistical Programmer Job
Eingestellt von Yoh
Gesuchte Skills: Support, Sap
Projektbeschreibung
Top Skills You Should Possess:
- Clinical Trial Reporting
- Data Set Analysis
- Statistical Analyses
What You'll Be Doing:
- Utilizes SOPs and guidelines, trial protocols, annotated case report forms, Oracle Clinical study definitions, trial and project data handling rules and standards, and Statistical Analyses
- Plans in preparation for the programming of the Data Quality Review Plan (DQRP) and the safety and efficacy tables, listings and graphs (TLG) required for the Clinical Trial Report (CTR) and the associated Analyses Data Sets (ADS).
- Review the programming specifications and table mockups in the Trial/Project/Substance Statistical Analyses Plan (T/P/S/SAP) for completeness, correctness and adherence to sited department guidelines and SOPs.
- Ensure all programming issues are resolved and updated in the T/P/S/SAP
- Ensure additional specifications once programming commences are properly documented.
- Transform specifications in the Trial/Project/Substance/Statistical Analyses Plan (TSAP) into fully documented, validated programs supporting both safety and efficacy displays and Analyses Data Sets (ADS) required for the Clinical Trial Report
- Provide support for the electronic submission to regulatory agencies worldwide
- Perform validation activities to ensure the quality of the electronic submission
- Provide fully documented, validated programs utilizing project or substance data bases in support of integrated reporting for regulatory agencies, Investigator Brochures (IB), Monitoring Committees, etc
What You Need to Bring to the Table:
- MS Statistics/BS Computer Science or Math
- One to three (1-3) years of experience supporting clinical trials
OPPORTUNITY IS CALLING, APPLY NOW!
RECRUITER: Chelsea Tevis
Yoh, a DayTHIS ADDRESS IS EXCLUSIVELY FOR INDIVIDUALS WITH DISABILITIES REQUESTING APPLICATION ASSISTANCE.
J2W: SCIENTIFIC; J2W: ENG; J2W: INFOTECH
MONJOBJ2WNECLIN
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Ridgefield, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
SAP Entwicklung, Sonstiges