Manager Biostatistics, Real World Evidence
With site/staff level of responsibility, manage a team of Biostatistics staff. Provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying statistical methods to project work. Communicate on project progress, staffing concerns, including resource allocation, with the Director, Biostatistics, as needed. Perform expert reviews jointly with other Biostatistics management staff. Participate in client meetings. Participate as senior statistician on major projects, including developing/reviewing protocols, preparing analysis plans, overseeing the conduct of analyses, and preparing integrated clinical and statistical reports. Provide training, guidance and mentorship to lower level and new staff.
• Production of High-Quality Deliverables: Ensure the high quality and timeliness of deliverables from the department and ensure the high quality of the expert review process.
• Leadership: Where relevant, may include: Serve as a statistical consultant for other members of the department and staff members from other Biostatistics departments within the company. Maintain knowledge and awareness of developments in Biostatistics and clinical trial methodology, and regulatory requirements that impact analyses. May participate as a member of a Data and Safety Monitoring Committee. May participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication, as approved. May participate as high level lead biostatistician on major project(s) including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries as required. Provide advanced technical expertise for internal and external clients. Assist and contribute to governance structures where relevant.
• Management: Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems, ensure compliance with operational components (e.g. Standard Operating Proceures (SOPs), Timesheets). Approve actions on human resource matters. Accountable for the project level work of staff including awareness of timelines, scope and resourcing strategy. Responsible for guiding leads toward financial success at a study level.
• Compliance: Ensures compliance with strategy and initiatives. Implements strategy and initiatives and collects feedback from the implementation (e.g. metrics). Develop and/or provide training to staff across the business unit. May provide feedback to draft strategy and initiatives.
• Knowledge Sharing: Develop and/or provide training to staff across the business unit. May be expected to act as subject matter expert (SME).
• Risk Management: Maintain client relationships and manage risks in order to minimize escalations. Serve as a primary point of contact for study leads and study level escalations
• Collaboration: Collaborate with business units with whom biostatistics closely interacts, such as data management (DM) and epidemiology (EPI), to facilitate existing processes and to identify issues requiring process change.
• Proposals: Able to review and comment on proposals/budgets at a study level. May contribute to request for proposals (RFPs). Assist in sales/individual study defense meetings as required. May be expected to present at bid defenses.
• Other Responsibilities: As defined on ad-hoc basis by senior managers. Perform Senior Biostatistical Review, where applicable.
• Bachelor's Degree Biostatistics or related field and 5 -7 years relevant experience including 1 year in a leadership capacity Req Or
• Master's Degree Biostatistics or related field and 5 -7 years relevant experience including 1 year in a leadership capacity Req Or
• Ph.D. Biostatistics or related field and 3 years relevant experience including 1 year in a leadership capacity Req
• Typically requires 5-7 years of prior relevant experience, including 1 year experience managing staff or equivalent combination of education, training and experience.
• Requires knowledge of basic management approaches such as work scheduling, prioritizing, coaching and process execution.
• Familiarity with most complex statistical methods that apply to Phase I-IV clinical trials.
• In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Strong working knowledge of SAS and/or R.
• Excellent written and oral communication skills with good interpersonal skills.
• Very good problem solving skills.
• Excellent presentation skills.
• Sound judgment/decision making.
• Ability to lead and motivate a team.
• Knowledge of Clinical Data Interchange Standards Consortium (CDISC) guidelines.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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