Biostatistical Expert Leader

Job Description

As a Senior Biostatistician, you will play a pivotal role in leading collaborations with clinical investigators to determine study design. You will contribute to protocol development, author statistical analysis plans, perform statistical analysis, make statistical inference and write / present reports summarizing findings including publications in peer-reviewed journals.

• You will manage statistical activities for a clinical study or platform of clinical studies.
• Supervise Biostatisticians, Associate Biostatisticians, and SAS programmers, direct their work on clinical research studies, provide expert consultation to projects across the company on statistical methodology, solve problems of complex statistical scope.
• Provide technical review of proposed statistical design for research studies across company, serve as the lead Biostatistician on one or more study projects.
• Participate in statistical process development and improvement across company, present at statistical conferences, provide sound strategic, scientific and statistical input to support client's research projects.
• Lead the project team's development of study analysis plans and statistical programs to perform analyses and display study data.
• Keep abreast with current statistical and medical literature to ensure that sound methodologies are adopted.
• Foster innovation in Biostatistics that will continuously enhance current statistical knowledge and practices.
• Ensure the scientific integrity of the research project and the accuracy of the reported results.
• Perform sample size calculation and provide leadership in the statistical design of research projects.
• Review protocols and case report forms to ensure that protocol objectives are met, and standards are maintained.
• Develop study assignment allocation schemas along with appropriate documentation.
• Lead the development of the methods and results sections of clinical study reports and scientific publications.
• Represent EMMES on behalf of clients at regulatory meetings.
• Provide expertise in methodological advances both internally and externally to improve statistical methodologies.
• Participate in the development and updating of Standard Operating Procedures.