Statistician

Job ID: BSSI –S-2010
Posted: July 7, 2010
Company name: BioStat Solutions, Inc.
Industry: Consulting – Drugs/Biologics/Devices
Location: Mt Airy, Maryland
Entry level: Yes
Term: Full time, Permanent
Reports to: Manager, Biostatistics

BioStat Solutions, Inc. (BSSI) is a statistical consulting corporation in service to leading pharmaceutical and biotechnology industries worldwide. Our philosophy establishes a robust approach to biostatistics in the design and analytical support of pre-clinical/clinical trials for drugs, biologics and medical devices.

Job Objective:

To apply statistical methodology in design and data analysis for pre-clinical and Phase II, III and IV clinical trials.

Details:

• Provide analytical support to pharmaceutical and biotechnology industries in accordance with client needs and BSSI managerial requirements
• Recommend statistical methods for data analysis in complex trial designs
• Apply statistical methodology in areas of vaccine development, diagnostic device development, biomarker development, microarray quality control and analysis, process/assay validation, pharmacokinetic/pharmacodynamic analyses, and pharmacogenomics
• Create SAS programs to implement linear regression models, linear mixed models, generalized linear models, generalized linear mixed models, non-linear models, survival analysis, simulation studies (e.g. MCMC) and power/sample size estimation
• Generate tables, figures and listings for presentation and interpretation of results
• Draft statistical methods sections for analysis plans, protocols and regulatory documents as needed, and summarize results for inclusion in statistical analysis reports (SARs)
• Perform peer-review of SAS programs in accordance with quality assurance/quality control

(QA/QC) policies

• Conduct work in accordance with BSSI standard operating procedures (SOPs), BSSI QA/QC policies, client-specific requirements and applicable regulatory guidelines
• Collaborate with team members towards achieving company objectives
• Communicate results and data-specific issues to BSSI management and clients as appropriate

Qualifications:

• PhD in statistics or biostatistics
• Proficiency in SAS programming and macros required
• Training in the theory and application of linear regression models, linear mixed models, generalized linear models, generalized linear mixed models, non-linear models, survival analysis, simulation studies (e.g. MCMC) and power/sample size estimation
• Experience in application of statistics to biological systems or genetics
• Proven ability to work independently and in a team environment
• Excellent analytical and problem-solving skills
• Excellent written and verbal communication skills
• Qualified candidates must be legally authorized to be employed in the US

Please apply to This e-mail address is being protected from spambots. You need JavaScript enabled to view it