Leads collaborations with clinical investigators to determine study design, contributes to protocol development, authors statistical analysis plans, performs statistical analysis, makes statistical inference and writes and presents reports summarizing findings including publications in peer reviewed journals. Manages statistical activities for a clinical study or platform of clinical studies.
Responsibilities
- Provides sound strategic, scientific and statistical input to support client's research projects.
- Serves as the lead Biostatistician on one or more study projects.
- May supervise Biostatisticians, Associate Biostatisticians and SAS programmers (all levels) and direct their work on clinical research studies.
- Leads the project team's development of study analysis plans and statistical programs to perform analyses and display study data.
- Keeps abreast with current statistical and medical literature to ensure that sound methodologies are adopted.
- Fosters innovation in Biostatistics that will continuously enhance current statistical knowledge and practices.
- Ensures the scientific integrity of the research project and the accuracy of the reported results.
- Performs sample size calculation and provides leadership in the statistical design of research projects.
- Reviews protocols and case report forms to ensure that protocol objectives are met, and standards are maintained.
- Develops study assignment allocation schemas along with appropriate documentation.
- Leads the development of the methods and results sections of clinical study reports and scientific publications.
- Represents EMMES on behalf of clients at regulatory meetings.
- Participate in the development and updating of Standard Operating Procedures.
- Performs other duties as assigned
- Complies with all policies and standards
Qualifications
- Master's Degree biostatistics, statistics, or related field. Required
- 4-6 years of related experience is expected but not required for the position. Required
- 1-3 years Demonstrated proficiency with statistical methods and applications in clinical research. Required
- 1-3 years Strong programming skills in SAS and/or R. Required
- Excellent communication, interpersonal and organization skills. High
- Ability to manage multiple tasks. High
- Ability to work independently, as well as in a team environment. High
- Ability to effectively communicate technical concepts, both written and oral. High
