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Regulatory Statistician

Location : Morrisville, NC
Job Type : Contract
Reference Code : 7911
Hours : Full Time
Travel : No
Relocation : No

Job Description :

The REGULATORY STATISTICIAN will support the statistical needs for Company Regulatory Science Group.


Regulatory Science conducts studies that are critical components of dossiers submitted globally to support the safety assessments of biotech products.


Job Description:

• Provide statistical support and conduct statistical analysis for regulatory studies, specifically agronomic, composition, protein expression, human and animal safety, environmental studies, laboratory assays and method validation.

• Provide statistical expertise to support the safety evaluation of biotech products under GLP environment. Participate in protocol development and experimental design.

• Generate tables, listings and figures using SAS reporting and graphic tools. Prepare high quality statistical reports and relevant supporting documents. Archive analysis packages.

• Validate/QC statistical analysis results generated by other statisticians.

• Interact with biotech study directors, scientists and regulatory/QA managers.

• Present results to the supervisor or client and inform of project advancement. 



Required Qualifications :


• PhD in Statistics/Biostatistics with minimum of 1 year of relevant experience,

MS with minimum of 2-4 years relevant experience or BS with minimum of 4-6 years relevant experience.

• Familiar with experimental design, sample size calculation, linear models, especially SAS mixed procedure, non-linear models, multivariate and categorical data analyses.

• Strong SAS programming skills in areas of data handling, modeling and graphics.

Experience in R.

Familiar with Microsoft Office.

• Self-organization, planning and problem-solving skills. Exceptional attention to detail.

• Constructive and proven team working attitude. Preferred Qualifications: • Experience in agricultural biotechnology regulatory studies.

• SAS certificates preferred.

• Excellent communication and technical writing skills in English.

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* Your eligibility for benefits depends upon your placement, hours billed and length of service. Your recruiter can identify the programs for which you are eligible. The Company reserves the right to modify or eliminate any of its non-legally mandated benefits at any time.