The Biostatistician II is responsible for having a working 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
- 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.
- Development of tables of summary statistics and graphics for clinical aspects of clinical trials.
- Assist in answering deficiency letters from regulatory agencies, as required.
- Utilize SAS to validate statistician programs and results.
- 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.
- Follow department and company standard operating procedures (SOPs), forms, templates and policies.
- Act as Lead Biostatistician for simple to complex studies and be the central point of contact for the assigned Biostatistics team, extended internal project team and the client .
- Provide input for Biostatistics portion of project timelines.
- Review of protocols for simple to complex studies.
- 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 participate or lead departmental or interdepartmental quality improvement initiatives.
- Maintain and participate in the objectives of the department.
- Other duties as assigned.
Bachelor's Degree or higher in Statistics or related field.
- Excellent verbal and written communication skills.
- Professional attitude and strong interpersonal skills.
- Ability to work well with a multi-disciplinary team of professionals.
- Client-focused approach to work.
- Flexible attitude with respect to work assignments and new learning.
- Ability to prioritize workload.
- Superior attention to detail.
- Understanding of clinical research project life cycle and applicable regulatory guidelines.
- Good computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to information technology (IT) systems as needed.
- Moderate SAS programming proficiency.