Job Description
Summary
Job Overview
With global impact and oversight, manage a department of Biostatistics and Statistical Programming staff ensuring that target productivity (project allocations, utilization, and output) levels are met. May fulfill the role of site head or functional head within a site. Manage direct personnel reports typically consisting of Manager to Associate Director level staff from each function. Participate in sales meetings as required and oversees departmental proposal preparation. Monitors budget and scope of within-office projects and takes action necessary to maximize realization. Ensure that departmental staff contribute to intra- and interdepartmental process improvement to achieve "best practices". Ensure that appropriate levels of professional development and training are provided to staff. Serve as a Biostatistical resource for the department, ensuring scientific integrity in the application of statistical methodology to clinical trials. Provide statistical direction, technical oversight, or consultancy on major projects or on projects involving particularly complex statistical analyses. Represent clients at the Food and Drug Administration (FDA) or other scientific meetings as required.
Essential Functions
• Production of High-Quality Deliverables: Ensure the high quality and timeliness of deliverables from the Biostatistics department. Oversee and ensures the high quality level of the Biostatistics 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. Represent clients at meetings with regulatory agencies or other regulatory meetings, 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 and/or new drug application (NDA) sections, 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 Procedures (SOPs), Timesheets). Approve actions on human resource matters. Accountable for the project level work of staff including awareness of resource reports/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.
• Financials: Client leaders are accountable for controlling cost and maximizing revenue at a client/service group level. Regarding ownership of operational components, ensure remit is in line with or maximizes business unit needs to control costs and maximize revenue recognition. Participate in monthly project review and operations meetings.
• Strategy and Initiatives: Defines overall strategy and initiatives for service group or client in line with business segment owners and business unit expectations. Contributes to global strategy and Initiative discussions with the Senior Directors. May provide training. Owns/Project Manages defined strategies and initiatives from the Senior Directors including delegation of components of strategy and initiatives to Associate Directors, when it is of when appropriate. Collaborate with other business units to develop strategies for process improvement. Customer: Develop, maintain and expand key client relationships. Act as Client/service group owner where significant business unit portfolio presence exists. Own operational pieces of the business segment (e.g. resource management for a business segment, recruitment management for a business segment). Take responsibility for client/service group level strategies and initiatives. Identify opportunities for additional business from existing clients and seek to develop new clients/service offerings.
• Risk Management: Manage risks to project delivery and/or quality. Able to manage and accountable for all study level escalations. When managing leads: operate as an escalation point for Biostatistical team leads
• Proposals: Participate in sales meetings, as required. Contribute to marketing materials. Create budgets, propose adjustments, and be able to discuss budget assumptions with clients, as well as the ability to understand and discuss pricing models. Write proposals and budgets at a study/submission level (may have experience drafting partnership proposals). Attend project defenses that could potentially expand the account and act as Primary Point of Contact (POC) for New Account Defenses. Explore new business growth opportunities and provide input into strategies that will enable Biostatistics to capitalize on those opportunities. Take a leadership role in project defenses that could potentially expand the account and Primary Point of Contact (POC) for New Account Defenses. Explore new business growth opportunities and provide input into strategies that will enable Bios to capitalize on those opportunities.
Qualifications
• Bachelor's Degree Biostatistics or related field and 11 years relevant experience including 4 years experience managing staff Req Or
• Master's Degree Biostatistics or related field and 11 years relevant experience including 4 years experience managing staff Req Or
• Ph.D. Biostatistics or related field and 7 years relevant experience including 4 years experience managing staff Req
• Typically requires 11+ years of prior relevant experience, including 4 years experience managing staff or equivalent combination of education, training and experience.
• Requires broad management knowledge to lead teams, and well as the ability to influences others outside of own job area regarding policies, procedures, and goals.
• 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.
• Excellent written and oral communication skills with excellent interpersonal skills.
• Excellent problem solving skills.
• Excellent presentation skills.
• Excellent judgment/decision making.
• Leadership and line management skills.
• Some demonstrated success of operation within senior/executive management teams.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium (CDISC)/ADaM).
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