The Principal Biostatistician is responsible for having expert knowledge of all related processes with the ability to independently lead a study, support analysis, and provide high?quality documents to support sponsors' research programs, and deliver a high level of quality and timeliness, resulting in high levels of client satisfaction. In addition, the Principal Biostatistician has an active role in continuous improvement within the Biostatistics department and in successfully delivering challenging client deliverables.
- Follow department and company standard operating procedures (SOPs), forms, templates and policies. Provide feedback and update these guidelines as needed.
- Lead Biostatistician for moderate to complex studies or programs of studies.
- Mentor, guide, and train other Biostatisticians in all aspects of the Lead Biostatistician role and all other tasks.
- Provide input for Biostatistics portion of project timelines.
- Review and provide statistical guidance for protocols of simple to complex studies.
- Create and provide Biostatistics-related training to create and sustain a culture of continuous improvement.
- Generate randomization schedules using SAS or randomization-specific software.
- Develop and quality control (QC) review statistical analysis for simple to complex studies.
- Develop or assist in developing the Statistical Analysis Plans (SAPs) and related table, figure, and listing (TFL) shells for studies of simple to moderate complexity.
- Develop tables of summary statistics and graphics for clinical aspects of clinical trials.
- Responsible for answering deficiency letters from regulatory agencies, as required.
- Validate Biostatistician programs and TFL results using SAS.
- Perform QC review of analyses and documents prepared by other team members for completeness, accuracy, consistency, and structure.
- Coordinate with internal team to deliver high-quality documents in accordance with agreed upon timelines.
- May represent Biostatistics in client and inter-departmental meetings.
- Conduct all work in compliance with SOPs, Good Clinical Practice (GCP), and all regulatory guidelines.
- Maintain familiarity with client and internal team expectations and produce analyses and documents consistent with these.
- Have awareness of regulatory guidelines of related authorities (Therapeutic Products Directorate [TPD], FDA, European Medicines Agency [EMA], etc.) as well as ICH and GCP procedures.
- May lead or participate in departmental or interdepartmental quality improvement initiatives.
- Maintain and participate in the objectives of the department.
- Oversee direct reports as assigned.
- Other duties as assigned.
- Junior level biostatisticians
Masters Degree or higher in Statistics or related field.