Senior Manager Biostatistics

Senior Manager Biostatistics

Primary Responsibilities

The Senior Manager, Biostatistics is responsible for leading the team of Biostatisticians and/or Statistical Programmers in the design, analysis, and interpretation of clinical study data ensuring efficient production of high?quality client and internal deliverables. They take accountability for overall planning, organization, and coordination of Biostatistics and/or SAS programming support for all assigned studies and programs.  The Senior Manager, Biostatistics is also responsible for employee recruitment, training, and retention as well as collaboration to meet department quality and financial goals.

The Senior Manager, Biostatistics is responsible for demonstrating strong department leadership that ensures client and internal communication is clear while creating a culture that demonstrates continuous improvement.

Tasks performed

• Follows department and company standard operating procedures (SOPs), forms, templates and policies. Provides feedback and update these guidelines as needed.
• Manages deliveries and ensures assigned studies or clinical programs achieve timelines and quality per contractual agreements and sponsor and company expectations.
• Provides guidance for all statistical and/or programming aspects of studies such as design, randomization, statistical analysis plan, analysis, data presentation, and interpretation of results.
• Manages assignment of Lead Biostatisticians and Lead Statistical Programmers to studies and clinical programs.
• Identifies project risks and issues and actively participates in escalation and resolution.
• Proactively works with cross-functional team members and other departments to anticipate client needs and ensure common understanding and commitment/alignment.
• Attends study team meetings and provides feedback regarding timelines and issue resolution as needed.
• Maintains compliance and ensures departmental awareness of regulatory guidelines of related authorities (Therapeutic Products Directorate [TPD], Food and Drug Administration [FDA], European Medicines Agency [EMA], etc) as well as the International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) procedures.
• Maintains strong knowledge of Clinical Data Interchange Standards Consortium (CDISC) requirements to meet regulatory standards.
• Develops quality processes and maintains corresponding documentation (SOPs and Work Instructions [WIs]).
• Leads and participates in intradepartmental or interdepartmental process and quality improvement initiatives. Including both technological and process improvements leading to improved deliverable quality and department efficiency.
• Collaboratively develops training plans and training for all roles within the Biostatistics department.
• Oversees direct reports.
• Supports management in evaluating staffing needs.
• Other duties as assigned.

Direct reports

Biostatisticians; Statistical Programmers; and Quality Control (QC) Auditors