Manager, Biostatistics

Job Summary

Lead a team of Biostatistics professionals with responsibility for site and staff management. Guide and oversee project execution, client engagement, and collaboration with internal departments by applying advanced statistical methodologies. Maintain communication on project progress, staffing, and resource allocation with senior leadership. Deliver expert review and consultation alongside biostatistics leadership and participate in client interactions. Act as a senior statistician on key projects, including protocol development, analysis planning, conducting analyses, and drafting integrated clinical and statistical reports. Mentor and provide training to junior and new team members.

Key Responsibilities

• Provide leadership, including statistical consulting within and across biostatistics departments, staying current on biostatistical and clinical trial methods as well as regulatory standards.
• Serve on Data and Safety Monitoring Committees or engage in research, teaching, and publication activities as approved.
• Lead biostatistical activities for major projects, such as protocol review, analysis plan creation, and report writing including drug application materials.
• Offer advanced technical expertise to internal and external clients and contribute to governance frameworks where applicable.
• Collaborate with business units like data management and medical writing to enhance existing processes and identify needed improvements.
• Conduct bi-monthly meetings with direct reports to review project status, team performance metrics, financials, risk assessments, training, administrative duties, personnel matters, and career development goals.
• Drive plans to measure and enhance employee engagement globally with consistency.
• Work with project leads to manage work schedules, staffing, technology needs, and anticipated workload peaks globally, developing accountability plans.
• Communicate leadership directives effectively to teams and escalate issues/opportunities appropriately.
• Ensure coverage for direct reports during absences or turnover by serving as designated substitute or arranging alternatives.
• Participate in bid defenses, kickoff meetings, and support requests for information, pricing, and budgeting as needed.
• Support both internal and external audits and inspections, ensuring trained staff participation.

Required Qualifications

• Bachelor's in Biostatistics or related field with 10 years of relevant experience including at least one year in leadership, or
• Master's in Biostatistics or related field with 10 years of relevant experience including leadership, or
• Ph.D. in Biostatistics or related field with 3 years of relevant experience including leadership.
• Typically requires 5-7 years prior relevant experience with at least one year managing staff or equivalent combination of education and experience.
• Knowledge of management techniques including scheduling, prioritizing, coaching, and process execution.
• Familiarity with complex statistical methods applicable to Phase I-IV clinical trials.
• Proficiency in SAS programming.
• Strong understanding of Clinical Data Interchange Standards Consortium (CDISC) specifications.
• Demonstrated staff management, leadership, motivation, and influence capabilities.
• Excellent organizational, metrics, and time management skills.
• Strong oral and written communication skills.
• Ability to juggle multiple assignments and prioritize effectively.
• Skilled mentoring and coaching abilities.
• Effective in matrixed service delivery with shared responsibilities through proactive communication and facilitation.
• Good judgment, problem-solving, and decision-making aptitude.
• Able to build and maintain effective working relationships with coworkers, management, and clients.
• Capable of independent work, following guidelines, and taking initiative.
• Understanding basic project finance concepts such as EAC, forecasting, burn-rate monitoring, and out-of-scope recognition.
• Competent in driving business and financial outcomes in the short and long term.
• Proactive risk evaluation and resolution seeking with appropriate communication to relevant parties.
• Exhibits sound judgment when seeking senior input by clearly outlining issues, backgrounds, required support, and recommended actions.

Additional Information

IQVIA is a global leader providing clinical research services and healthcare insights to life sciences industries, supporting innovative medical treatment development to enhance patient outcomes worldwide.

Integrity in the hiring process is paramount. All applications must be truthful and complete. Any false information or omissions will result in disqualification or termination in accordance with law.