Senior Manager, Clinical Research (Statistics)

Job Description

Manages daily operation of all clinical research programs in the department to achieve objectives with either small portfolios at multiple sites or a single, larger portfolio. Coordinates resources to achieve the goals of conducting responsible research. Develops, manages and evaluates all research team members. Manages capital equipment requests and programs related to research.

Job Responsibility

• Develops, communicates, and builds consensus for goals in alignment with system
• Regularly collaborates work with leadership and others outside of own function
• Works on moderately complex matters where analysis of issues, data, processes and situations require an in-depth knowledge of objectives in aligned area as well as in-depth industry and technical knowledge
• Assignments are often self-initiated. Determines and pursue courses of action necessary to obtain desired results
• Provides leadership to team members, supervisors, and managers by communicating and guiding toward achieving department objectives with either small portfolios at multiple sites or a single, larger portfolio
• Provides direction and guidance to exempt specialist, supervisory, and/or middle management personnel who exercise significant latitude and independence in their assignments
• Typically responsible for managing team members and executing policies at multiple sites or a single, larger portfolio
• Assists in career development planning for team members
• Participates in development and oversees implementation of clinical trial activities including final research protocols, data management and trial management plans.
• Recommends and oversees implementation of approved development and integration of risk management plans to identify and address potential problems with program performance, timeliness and quality of results.
• Participates in staffing and resource planning and allocation across clinical trial projects; coordinates training, quality assurance and site evaluations.
• Responsible for acquiring and managing staffing appropriately for department(s) and collaborating with HR to fulfill requirements
• Responsible for performance reviews, corrective actions, promotional decisions, and pay actions for direct reports
• Manages budget expenditures for teams and/or large projects
• Recommends documents generated by clinical research including, but not limited to protocols, study reports and regulatory documents supporting Investigational New
• Drugs (INDs), New Drug Applications (NDAs) and Food and Drug Administration (FDA) information requests.
• Provides regularly scheduled reporting to program executive leadership, sponsors, and program team; reviews quality assurance reports generated by the data management core and develops plans with sites for corrective actions, as needed.
• Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.

Job Qualification

• Bachelor's Degree required, or equivalent combination of education and related experience. Master's Degree, preferred.
• 6-10 years of relevant experience and 5-7 years of leadership / management experience, required
• Proficiency in statistical software (e.g., R, Python), required.

Preferred Skills:

• Experience in public health research, clinical trials, preferred.
• Experience with managing healthcare data (EMR/EPIC), preferred.
• Familiarity with IRB processes, REDCap, and health data governance.
• Proven ability to manage interdisciplinary teams and collaborate across administrative, academic, and clinical domains.
• Strong communication and interpersonal skills; ability to convey complex statistical concepts to diverse audiences.

• Manages a Biostatistics group by guiding staff, fostering collaborations, and building consensus for programs and initiatives that align with the needs of the department(s) and/or organization.
• Develops, formalizes, and implements policies and procedures governing biostatistical services, data management and governance, and the execution of analytical projects.
• Identifies opportunities to improve data workflows and analytic processes across the organization.
• Collaborates with clinical investigators/researchers, facilitates discussions, and communicates clearly across all levels, leveraging these relationships to streamline and improve project management.
• Uses statistical knowledge (techniques and software) to manage and analyze data.
• Collaborates with investigators to provide expert guidance throughout the research lifecycle-including study design, implementation, data analysis, and interpretation of results.
• Provides education and training in statistical methods and applications, as needed.

Additional Salary Detail

The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future.When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).