Biostatistician III

Location: Boston, MA

Description:

The biostatistician acts independently and as a member of a research team, to provide statistical support in the design, implementation, conduct, and analysis of clinical trial and/or observational study data. The biostatistician works with other biostatisticians and programmers, and collaborates with a variety of people from academic, government, and pharmaceutical industry partner organizations.

Major duties and responsibilities:

  • Serve as a lead biostatistician to create, test, document, and archive programs used for national and international clinical trials and observational studies of treatments for HIV and other infectious diseases analyses
  • Perform tasks related to statistical analyses, programming, and procedures, such as:
    • Write guidance documents for submissions;
    • Draft operating procedures and work instructions;
    • Create SAS macros to facilitate data preparation and data analysis.
  • Organize and maintain directories containing electronic documents, data, analysis programs, and reports
  • Determine and write statistical considerations for protocol documents
  • Write statistical analysis plans; determine proper summary statistics, report formats and address analysis considerations
  • Develop screening and randomization documents
  • Review and provide input for proposed study methodology, outcome measures, and other portions of proposals and protocols to ensure conformance with accepted statistical principles and ICH guidelines
  • Provide input into data collection form development and data management methods to ensure data will meet study objectives
  • Develop screening and randomization documents
  • Ensure integrity of data collection, review, compilation and analysis by monitoring protocols and procedures; identify scientific problems; suggest and implement corrective action
  • Conduct ongoing, periodic and final analyses of data, using specialized statistical techniques and statistical programming
  • Prepare periodic and ad hoc data status reports
  • Attend professional meetings and short courses to expand or maintain professional knowledge and expertise, and lead informal seminars and training sessions for FS statisticians
  • Participate in writing and peer review/critique of analyses, reports, abstracts and manuscripts
  • Supervise and train junior statisticians and/or programmers
  • Participate in other biostatistical work at FS, such as Independent Data Monitoring Committees (IDMC) or newly funded proposals, as needed.

Reports to: Director of Biostatistics

Controls over position: Work assigned based on project needs.

Required qualifications:

  • M.S. in Biostatistics/Statistics or equivalent
  • At least 10 years of experience as a Biostatistician, or similar position, along with a proven track record of success
  • Excellent command of SAS and/or R; strong working knowledge of MS Office Suite and excellent overall technical skills
  • Knowledge of clinical trials/research studies
  • Experience in phase I/II dose-finding studies, regulatory submissions, and/or supervising the creation and documentation of CDISC datasets
  • Considerable independence and self-direction
  • Ability to independently analyze data from clinical trials and observational studies using statistical techniques
  • Excellent oral and written communication skills
  • Strong attention to detail, excellent time management/organizational skills and ability to quickly pivot between tasks.

This position will be based out of the Boston, MA office but consideration will be made for a full time remote worker.

A cover letter must be submitted to be considered for this position.

Applications will be received through the ADP Workforce Now Career Center using the following link: ADP Workforce Now Frontier Science Career Center.

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, age, or veteran status.