100% Remote Biostatistician

Location: Cary, North Carolina Salary: competitive
Sector: Pharma & Biotech, Datenmanagement und Biostatistik Type: Contract

Job Description

  • Acts as lead statistician on projects of moderate to large size and complexity; supports lead statistician on very large, complex studies. May have staff management and/or project management responsibilities. Writes statistical reports. Aids in the development of protocols.
  • Becomes familiar with the activities outlined in the department's Working Practice Documents and contributes changes as needed.
  • Learns and follows departmental procedures for statistical analyses and programming work.
  • Serves as a lead statistician on moderate and large projects.
  • Leads a project team.
  • Conducts team meetings, maintains project timelines, assesses resources needed, provides resources, and prepares the budget.
  • Ensures that SOPs are being followed and that appropriate project documentation is ongoing.
  • Coordinates with programmers and data management personnel as to database maintenance, updating and documentation.
  • Provides guidance for database structures for analysis.
  • Creates or provides specifications for analysis databases based on Data
  • Management database.
  • Provides sample size calculations and reviews protocols for completeness, appropriateness of clinical design, and sound statistical analysis.
  • Provides randomization schemes and appropriate documentation.
  • Develops statistical analysis plan, including table and listing specifications, and guide others on the team in its implementation.
  • Programs/validates statistical tables with an emphasis on efficacy endpoints.
  • Provides proper documentation and oversee the work of others who assist in programming/validating.
  • Prepares and reviews reports, including interim reports, final Integrated Clinical and Statistical Reports, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents and manuscripts.
  • Contributes to the statistical methods section and verify for completeness and consistency for report.
  • Interacts with the sponsor on all aspects of the project.
  • Understands project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope.
  • Provides general infrastructure support to the Biostatistics Department.

Education and Experience:

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
  • MS/MA degree in statistics, biostatistics, mathematics or related field and two years experience preferred
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years') or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities:

  • Strong SAS® programming skills and understanding of database structures
  • Ability to promote teamwork in a multi-disciplinary team setting
  • Strong knowledge of statistical principles and strong statistical skills
  • Proven performance of required tasks, as evidenced in outstanding performance in current tasks and/or documented record of accomplishments
  • Evidence of strong management skills, as shown through management of multiple projects and/or staff members
  • Excellent written and verbal communications skills
  • Good organizational skills with the ability to adapt and adjust to changing priorities
  • Positive attitude and the ability to work well with others

Sthree US is acting as an Employment Business in relation to this vacancy.