Senior Biostatistics Leader - RWE & Regulatory

Capgemini Engineering; Almada; Presencial; EUR 120 000 - 180 000; Tempo integral

Resumo da oferta

IQVIA seeks a senior Biostatistician leader to provide advanced statistical leadership across projects, oversee analysis plans, and interact with regulatory bodies. You will guide protocol development, ensure compliance with CDISC/ADaM standards, and drive quality and efficiency in a fast-paced environment.

The role requires extensive experience in clinical trials, strong SAS expertise, and proven staff management capabilities to mentor teams and deliver high-quality submissions.

Qualificações

• 7–10 years of relevant experience including 2 years in staff management.
• Experience leading major projects and reviewing protocols and analysis plans.
• Familiarity with Phase I–IV clinical trials and regulatory expectations.

Responsabilidades

• Lead as biostatistician on major projects and develop analysis plans.
• Represent clients in regulatory meetings and provide governance support.
• Identify and mitigate risks to project delivery and quality.
• Hold regular meetings with directs reports to review status, timelines, and training.
• Contribute to bid defenses and input for RFIs/RFPs.
• Collaborate with cross-functional teams and external clients to ensure milestones are met.

Conhecimentos

Leadership

Budgeting

Project management

Communication

Negotiation

Data governance

Regulatory knowledge

Risk management

Problem solving

Staff management

Formação académica

Bachelor's Degree Biostatistics or related field

Master's Degree Biostatistics or related field

Ph.D. Biostatistics or related field

Ferramentas

SAS

CDISC/ADaM

Descrição da oferta de emprego

IQVIA seeks a senior Biostatistician leader to provide advanced statistical leadership across projects, oversee analysis plans, and interact with regulatory bodies. You will guide protocol development, ensure compliance with CDISC/ADaM standards, and drive quality and efficiency in a fast-paced environment.

The role requires extensive experience in clinical trials, strong SAS expertise, and proven staff management capabilities to mentor teams and deliver high-quality submissions.