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Associate Director, CSDD

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Primary Location: Durham, North Carolina, United States Full time R1258560

Job description

Job Overview


With regional/site presence, manage a team of Biostatistics staff. May fulfill the role of site head or functional head within a site.  Provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying advanced statistical methods to project work.  Serve as a resource for the department, ensuring scientific integrity in the application of statistical methodology to clinical trials.  Assist the Director in strategic planning and resource allocation for the department. Participate by offering oversight across studies and/or customers including guidance on documentation and output development/review.  Assist the Director in proposal development, project allocation, budget projections, and client presentation, as needed.  Conduct independent research and teache courses in statistical methodology as resources permit.

Essential Functions


• 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:  Serve as a Biostatistical 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 on analyses. Represent clients at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee. As approved, participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication. 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 or eSubmissions and/or new drug applications (NDA), 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 timelines, scope and resourcing strategy. Responsible for guiding leads toward financial success at a study level
• Financials:  Accountable for controlling costs and maximizing revenue recognition 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. Provides support to leads regarding estimate at completion (EAC) reporting
• Strategy and Initiatives:  If client head/service group owner, partners with management to define strategy and initiatives for particular client/service group. May provide feedback to draft 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. Ensures compliance with strategy and initiatives. Owns/manages components of larger strategy and initiatives. Owns/manages small focused initiatives and/or components of larger focused initiatives. Collaborate with other business units to execute strategies for process improvement
• Customer:  Client/service group owner with moderate or building business unit portfolio presence. Responsible for client/service group level Strategies and Initiatives.
• Risk Management:  Identifies risks to project delivery and/or quality. Anticipates risks to avert need for study level escalations, supports lead in implementing risk mitigation actions. Handles study level escalations and assist in high level escalations that might impact the account relationship. Escalates for support to business segment owners/client owners/managers. When managing leads, operate as an escalation point for biostatistical team leads
• Proposals  Participate in sales meetings as required (if a client head: attends defenses that could potentially expand the account). Able to review and are being trained to write proposals/budgets at a study/submission level, understanding of what goes into a budget, how to propose adjustments, and be able to discuss budget assumptions with clients as well as the ability to understand and discuss pricing models
• Other Responsibilities:  As defined on ad-hoc basis by senior management. May assist with cross functional collaboration. Perform senior biostatistical review (SBR), where applicable

Qualifications


• Bachelor's Degree Biostatistics or related field and 7 - 10 years relevant experience including 2 years experience managing staff Req Or
• Master's Degree Biostatistics or related field and 7-10 years relevant experience including 2 years experience managing staff Req Or
• Ph.D. Biostatistics or related field and 5 years relevant experience including 2 years experience managing staff Req
• Typically requires 7-10 years of prior relevant experience, including 2 years experience managing staff or Equivalent combination of education, training and experience.
• Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one department or multiple related departments.
• 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.
• Excellent written and oral communication skills with good interpersonal skills.
• Excellent problem solving skills.
• Excellent presentation skills.
• Sound judgment/decision making.
• Ability to lead and motivate a team.
• 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).

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

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