- Contract Opportunity
- Work Remotely - Work from Home
- 2 locations - United States or Belgium
- Once travel restrictions are lifted, travel to Boston, MA or Ghent Belgium will be 1-2 times a month
- Serves as a subject matter expert and lead in providing statistical, process and regulatory knowledge to the department. Acts as the senior reviewer on simple or moderately complex projects, and with additional oversight as needed on complex or highly complex studies. Acts as a project manager, overseeing the statistical and programming aspects of clinical trials from design, through analysis and reporting, acting as the lead statistician on multiple projects. Represents the department within the company and with interactions with client companies and regulatory agencies, on simple to complex study design matters, directly contributing to complex study proposals and bids, representing the department at bid defenses. Organizes teams and implements strategies to ensure process and programming efficiencies on complex studies.
- Provides expert knowledge within the department on statistical and regulatory issues, mentors members of the department and provides project guidance and statistical advice.
- Provides expert knowledge and experience of complex trials design across different therapeutic areas.
- Provides expertise in the development and delivery of training material, and the implementation of departmental procedures for the team.
- Contributes to process improvement and departmental initiatives.
- Serves as senior reviewer on simple or moderately complex studies as assigned with minimal oversight, and on more complex studies as assigned with supervision as needed.
- Serves as a lead statistician on multiple projects and leads project teams for multiple protocols.
- Conducts team meetings, maintains project timelines, assesses resource need, provides resources, and budget management.
- Ensures that SOPs are being followed and that appropriate project documentation is ongoing.
- Provides management with timely, accurate status and resourcing reports.
- Interacts with the sponsor on statistical aspects of the project and present at meetings as required.
- Produces sample size calculations.
- Provides input into study design and statistical considerations, during protocol development.
- Review protocols for completeness, appropriateness of clinical design and sound statistical analysis.
- Contributes to writing appropriate protocol sections.
- Leads the development and review of statistical analysis plans, including table, listing and graph specifications.
- Organizes the production of statistical analyses and statistical appendices, with appropriate documentation.
- Ensures that appropriate validation for statistical analyses and statistical appendices is implemented.
- Specifies the general structure of the analysis database, oversees its development, and ensures completeness for use in all programming.
Education and Experience:
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6 years’).
- Master's degree in statistics, biostatistics, mathematics or related field Extensive experience of statistics in a clinical trial environment.
- Evidence of providing expert statistical input in previous positions and presenting at
statistical conferences would be an advantage.
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Excellent understanding of the statistical principles underlying clinical trials
- Excellent statistical skills
- Excellent understanding of the regulatory issues associated with the reporting of clinical data in the submission process
- Regulatory submission and study/program design experience required
- Great consultative skills•Outstanding SAS® programming skills and familiarity of other statistical packages (eg StatXact, Nquery) and understanding of database structures
- Excellent organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
- Capable of adapting and adjusting to changing priorities
- Excellent written and verbal communication skills, including proficiency in the English language
- Capable of working in a multi-disciplinary team setting
- Demonstrated initiative, motivation and problem solving skills
- Positive attitude and the ability to organise a team and work well with others
- Good mentoring skills as shown by leadership of multiple projects and team members