Statistical Programmer

Yoh has a long term contract opportunity for a STATISTICAL PROGRAMMER to join our client located in Ridgefield, CT.

JOB RESPONSIBILITIES:

- 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).
- Produce well documented validated standard and non-standard edit check and monitoring programs to support the clinical trial team to ensure the integrity, accuracy and completeness of the data in preparation for clinical reporting.
- 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.
- Establish project and substance databases following the rules of good data base structure and data base integrity.
- 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.
- Help maintain libraries of fully documented and validated programs, macros and procedures which can be reused by other programmers to aid in the efficiency for the department.

JOB QUALIFICATIONS:

- MS Statistics/BS Computer Science or Math.
- One to three (1-3) years of experience supporting clinical trials.

DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.

Yoh is a professional staffing provider with over 70 years of experience in the short and long-term staffing services industry; visit our website to learn more about our company.

Yoh, a Day and Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC; J2W: CLINICAL

J2W: INFOTECH

Tax Term: CON_W2

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SFSF: LS