Crowd Staffing

Minimum Qualifications

Education:

Master’s degree in Statistics or Biostatistics with at least two years related experience

Skills:Required

• PHARMACEUTICAL FDA
• SAS
• STATISTICAL ANALYSIS
• BIOSTATISTICS

• Minimum 2 years experience in BIostats role within Pharamceutiocal or Diagnostics industry.
• Minimum 2 years Manufacturing and product development Pharmaceutical/Biotechnology industry experience (assay validation, product specification setting, OOS, SPC, process optimization, etc.).
• Minimum 2 years experience managing people in a Biostats or clinical capacity.
• Demonstrated sound knowledge of statistical applications to clinical and nonclinical projects. Demonstrated technical expertise across a range of commonly used statistical methodology.
• Knowledge of appropriate regulations and guidance documents. Broad experience across a range of clinical and nonclinical projects and demonstrated support of diverse client needs.
• Demonstrated management and leadership skills.
• Skilled SAS® programming knowledge.
• Demonstration of innovation by development or novel application of statistical methods.

• Sound knowledge of theoretical statistics and statistical applications
• Must have proficiency as an SAS programmer
• Knowledge of FDA regulations and guidelines is a plus.
• Good communication and presentation skills.
• Ability to work effectively in both in a team environment and independently.
• Ability to work on several projects simultaneously.
• Possess good problem solving skills.
• Self-motivated
• Capable of addressing unique problems
• Experience in the diagnostics area is preferred.

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• Developing consultation skills that include design, and data management issues for clinical and nonclinical projects.

• Work with project teams to produce protocols, analysis plans and final reports for clinical and nonclinical projects.

• Plan, coordinate and produce statistical analyses, summaries and write formal memoranda.

• Produce SAS programming and other software package programming to analyze data.

• Interpret the project implications of regulatory guidelines. Interact with FDA, other regulatory or auditing agencies as appropriate in statistical aspects of study design, data analysis, and justification of statistical procedures.

• Represent Biostatistics on company-wide project teams. Serve as primary liaison between Biostatistics and key internal clients with regard to resource needs and timelines.

• If appropriate, interact with counterparts at companies collaborating with other Teams including proactively engaging with joint development corporate partners.

• Initiate methodological research in statistics to improve biostatistics methodology used in development products consistent with corporate priorities and timelines.

• Develop Clinical and Nonclinical Biostatistics procedures and guidelines to comply with corporate policies and procedures.

All your information will be kept confidential according to EEO guidelines.