Clinical Biostatistician
TKL Research, Inc. - Rochelle Park, NJ

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TKL Research is a full-service, international Clinical Research Organization (CRO) serving the pharmaceutical, biotechnology, medical device and consumer healthcare industries. We provide comprehensive clinical trial management services for Phase 1-4 clinical research studies, including an inpatient Phase 1 facility and outpatient specialized research clinics.

We are seeking a highly motivated Clinical Biostatistician for our growing organization!

The Clinical Biostatistician will provide statistical analysis in support of clinical projects; prepare tables, listings, and figures presenting clinical data summaries for inclusion in reports; assist in the preparation of statistical analysis plans for clinical trials; design data display formats for clinical study reports; provide statistical analysis for quality control; provide statistical support to TKL staff and in support of sponsor clients.

Responsibilities include, but are not limited to:
  • Support and assistance in preparation of Statistical Analysis Plans for clinical trials.
  • Design tables, listings and figures for statistical reporting.
  • Develop, test, maintain, and archive SAS program code to perform statistical analysis and generate analysis datasets and statistical reports of clinical data.
  • Perform statistical QC review of source code and output developed by other staff biostatisticians for statistical reports.
  • Perform statistical review of clinical data and communicate data issues to data management and clinical staff.
  • Design and prepare randomization schedules for clinical trials.
  • Maintain tracking sheets and other documentation.
  • Prepare Blind Data Review documents for clinical trials, including notes for special data handling and assignment of analysis populations.
  • Miscellaneous duties, as necessary, in support of Clinical Biostats and Programming initiatives and TKL business priorities and objectives.
Min Masters Degree in statistics or equivalent academic credential; health sciences field preferred. Understanding of the FDA, ICH, CDISC, and other applicable Guidelines related to the conduct of compliant clinical trials. Good understanding of basic statistical procedures and statistical methodology. Experience in SAS programming, including understanding of macros. Excellent organizational skills, written and verbal communication skills, and working knowledge of Microsoft Office Suite is a must.

We offer a competitive compensation package for full time employees, commensurate with your background and experience, including full benefits, 401(k) with match and a profit sharing plan.

This is a full-time position based in our Rochelle Park, NJ headquarters.