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Regulatory Statistician (195389)MorrisvilleNorth Carolina.

Regulatory Statistician (195389)

Morrisville | North Carolina | United States | 27560

Regulatory Statistician (Contract):

We here at HRU Technical Resources have partnered with an industry leading candidate to find a Regulatory Statistician who will help statistical needs for the regulatory science group. The regulatory science group conducts studies that are critical components of dossiers submitted globally to support safety assessments of biotech products.

Our client is a recognized pioneer in creating chemistry for a sustainable future. In this position you will provide statistical support and conduct statistical analysis for regulatory studies.

Responsibilities:

• 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.

About you:

• 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.

Position Type:  Contract               

Job Location:  Morrisville, NC

Benefits and Salary:

Pay- $52-$55/hr

Benefits: Health, Dental, Vision, 401k, Short term and long-term disability

More about us and our clients

HRU has developed a large network of available candidates nationwide, as the company has been providing recruiting and staffing services in up to 22 States for over 25 years. We specialize in engineering, IT, technical and other support services. We are able to recruit and successfully place candidates in job openings in a variety of other fields and positions as well, such as human resources, administration, management, purchasing, sales, customer service, accounting, organic chemistry and more. HRU is able to service clients, regardless of location, by assigning an Account Manager and experienced Recruiters to provide the necessary staffing and support services. Likewise, HRU may assist job seekers anywhere in the United States, regardless of location.

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