Senior Biostatistician (REMOTE)
Company: Mapi Group
Location: Gaithersburg
Posted on: March 20, 2023
Job Description:
- 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.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.QualificationsExperiencePreferred 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.
Proficient in Microsoft Office Suite and comfortable with Excel.
Equal Opportunity Employer/Protected Veterans/Individuals with
DisabilitiesThe 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)
Keywords: Mapi Group, Washington DC , Senior Biostatistician (REMOTE), Other , Gaithersburg, DC
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