- 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.