Biostatistician Job in Ellicott City, Maryland US
ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies. In a highly fragmented industry, we are one of a small group of organizations with the capability and expertise to conduct clinical trials and development projects on either a local or global basis. We have the operational flexibility to provide development services on a stand-alone basis or as part of an integrated "full service" solution.
The successful candidate will be responsible for statistical aspects of clinical and preclinical research projects. Project responsibilities include study design, case report form development, analysis planning and scheduling, analysis and interpretation of data, and reporting of results. May be required to coordinate analysis efforts across multiple research projects conducted for a client.
Role Responsibility
- Responsible for statistical aspects of projects, including experimental design, analysis, and presentation of data.
- Maintains consistent approaches within and across research projects.
- Serves as a statistical consultant and advisor in study design, sample size estimation, patient randomization, statistical analyses, and interpretation of data.
- Ensures that all project-related work is carried out in accordance with ICON SOPs.
- Develops study specific procedures (SSPs) for assigned projects as required and ensures that project team members adhere to the SSPs.
- Responsible for statistical aspects of CRF design.
- May serve as a Project Manager for projects that are primarily data management, biostatistics, or statistical programming in scope.
- Develops statistical analysis plans, including the definition of derived data sets and the design of templates for statistical tables, figures, and/or data listings for clinical summary reports.
- Understands and uses relevant computer languages and software packages. Writes programs to select, retrieve, manipulate, edit, and analyze data.
- Responsible for the accuracy and completeness of analyses conducted for assigned projects. Monitors and verifies statistical analysis programs written by junior statisticians and programmers.
- Conducts statistical analyses and interprets results of these analyses.
- Prepares statistical summary reports.
- 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.
- 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 and review of biostatistical 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.
- Assists in interviewing and training of new staff.
Experience Qualifications
- Bachelor Degree. Post Graduate education in relevant discipline is strongly desired.
- Minimum of 2 years clinical research/pharmaceutical or related experience.
- In-depth knowledge of study designs, and statistical analysis conventions in one or more therapeutic areas.
- Significant proven experience in a similar role.
- 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.
Come to ICON and be an important part of a well respected and growing company that believes the details of your career are every bit as critical as the work you do. You'll enjoy highly competitive compensation and an exceptional benefits package that includes: Medical, Dental, and Vision Insurance, Flexible Spending Accounts, Short Term and Long Term Disability, Life and ADD Insurance, 401K Plan with matching contributions, a generous program of Vacation, Holidays and Personal Time Off and more.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.