Assoc Dir, Biostatistics Rwe

Iqvia Argentina; Viseu; Presencial; EUR 70 000 - 110 000; Tempo integral

Resumo da oferta

IQVIA is seeking a regional Biostatistics leader to manage a team of Biostatistics staff, provide direction on project assignments, interface with clients, and apply advanced statistical methods to clinical trials.

You will assist the Director in strategic planning, oversee studies and outputs, contribute to proposals and budget projections, and help ensure scientific integrity while mentoring staff and teaching courses where possible.

Qualificações

• Leadership of biostatistics staff and cross-functional collaboration.
• Expertise in advanced statistical methods applied to clinical trials.

Responsabilidades

• Lead biostatistics staff and provide technical guidance.
• Manage risk and oversee study quality and documentation.

Conhecimentos

Biostatistics leadership

Clinical trial methodology

Regulatory knowledge

Descrição da oferta de emprego

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

• 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
• 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