Job Overview

With global impact and oversight, serve as site head of the local Biostatistics department ensuring that target productivity (project allocation, utilization, and output) levels are met. Manage an assigned group of high-level staff/management from the Biostatistics and Statistical Programming sections. Manage direct personnel reports typically consisting of Manager to Director level staff from each function. Plays a major role in sales meetings 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 Biostatistics is working as efficiently and effectively as possible with other departments. 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 for major projects or on projects involving particularly complex statistical analyses. Represent clients at FDA meetings, FDA advisory boards, or other scientific meetings as required. Fulfill a global role such as an executive client sponsor or working party lead.

Essential Functions

• Production of High-Quality Deliverables: Ensure the high quality and timeliness of deliverables from the Biostatistics department. Oversee and ensure the high quality level of the Biostatistics expert review process.
• Leadership: 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 a 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 and ensure compliance with operational components (e.g. Standard Operating Procedures (SOPs), Timesheets). Approve actions on human resource matters.
• 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 appropriate. Collaborate with other business units to develop strategies for process improvement.
• Customer: Service as client/service group owner where significant business unit portfolio presence exists. Own operational pieces of the business segment. Responsible 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.