Job Description :
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. Our Biostatisticians are responsible for statistical aspects of clinical and preclinical research projects. Project responsibilities include case report form development, statistical analysis and interpretation of data, and reporting of results.
Responsibilities :
- Assists senior biostatisticians in providing statistical support for clinical studies, including study design, sample size calculations, patient randomization, statistical analyses, interpretation of data, and reporting of results.
- Assists senior biostatisticians in statistical aspects of case report form design.
- Assists senior biostatisticians in writing statistical analysis plans, including the definition of derived data sets, and the design of statistical tables, figures, and data listings for clinical summary reports.
- Carries out project related work in accordance with ICON standard operating procedures (SOPs) and study specific procedures (SSPs).
- Writes data quality control specifications for projects as needed.
- Understands and uses relevant computer languages and software packages. Writes programs to select, retrieve, manipulate, edit, and analyze data.
- Monitors and verifies statistical analysis programs written by statistical programmers.
- Conducts statistical analyses and interprets results of these analyses.
- Prepares statistical summary reports under the supervision of senior biostatisticians.
- Writes the statistical methods sections of integrated study reports. Reviews and approves draft integrated study reports.
- Documents and archives analysis and programming work to ensure a complete audit trail. Participates in the setting of project document standards.
- Creates and maintains biostatistics files for each assigned project.
- Manages statistical projects for high quality, within budget, and on-time completion.
- Establishes and maintains effective working relationships with clients and ICON project team members, including data management personnel, statistical programmers, and clinical research personnel.
- Participates in presentations at client and investigator meetings.
- Assists in the preparation of biostatistics input to ICON research proposals.
- Researches and applies new statistical procedures as needed.
- Provides appropriate statistical input for regulatory submissions and responds to statistical questions raised by regulatory agencies.
- Excellent verbal and written communication skills are required.
- Knowledge in applied parametric and nonparametric statistics and strong SAS programming skills are a must.
- Must be able to translate clients’ needs into statistical practice and educate clients in the use of statistics.
Experience required : 2-7 years
How to Apply :
Interested candidates can send across their resumes to malarkannan.j@iconplc.com
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