Biostatistician II

ESSENTIAL FUNCTIONS:

• Recognize, exemplify and adhere to ICON GPHS's values which center around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• As a People Leader, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Responsible for statistical aspects of projects, including experimental design, analysis, and presentation of data. Maintains consistent approaches within and across research projects.
• Ensures that all project-related work is carried out in accordance with ICON GPHS 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.
• Assists clinical database administrators in the design of project databases, project database structures and data management coding conventions as necessary, writes quality control specifications for projects.
• Serves as a Project Biostatistician responsible for management of statistical tasks related to assigned projects
• Able to communicate blinded and unblinded summaries to DSMB members, sponsors, and regulatory agencies.
• May serve as a Project Manager for projects that are primarily data management, biostatistics, statistical programming, or scientific writing 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 (SAS, R, PASS, nQuery). 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.
• 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.
• Assists in technical training of new staff.
• Supervise and coach junior Biostatisticians in specific projects when designated
• Performs additional duties as assigned.

ICON Government and Public Health specializes in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with a wide array of research, regulatory, and sponsor services both within the US and around the globe and respond rapidly to global health crises.

Experience

• Master’s Degree or PhD in Statistics, Biostatistics, Epidemiology, or other relevant degrees. Experience supporting clinical research project teams for a CRO/Pharmaceutical/Biotech company is desirable.
• An understanding of quality control as it relates to regulatory documentation requirements is preferred.
• Proficient in SAS and relevant statistical procedures.
• Experience with infectious diseases not required but is desired.
• Experience with adaptive trials and Bayesian analysis techniques is desired.
• Able to work with and assist in the development and validation of CDISC datasets (SDTM, ADaM).
• Exceptional written and oral communication skills.
• Ability to problem-solve.
• Ability to work well in a team environment as well as independently as needed.
• Proficient in Microsoft Office Suite and comfortable with Excel.
• Detail oriented with planning and organization skills. Customer oriented.
• Must be able to work independently following a brief period of specific technical training.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)