Remote Lead Biostatistics Director – Biotech

IQVIA Argentina; Amsterdam; On-site; EUR 103,000 - 155,000; Full time

Job summary

IQVIA Biotech seeks a Lead Statistician to join its EU Biostats team as a senior leader across oncology drug development. You will provide expert statistical review of SAPs, ADaM specifications and TLFs, ensuring quality and regulatory readiness.

This role requires mentoring biostatisticians across Europe and JPAC, and engaging clients and regulators as a trusted advisor. The position is remote, offering collaboration with an international team and opportunities to shape statistical strategy,

Qualifications

• Masters or PhD in Statistics/Biostatistics or related field with CRO/biotech experience.
• Strong knowledge of GCP, ICH, and FDA guidelines for clinical trials.
• Proven leadership and mentoring abilities with global teams.

Responsibilities

• Collaborate with sponsors on statistical aspects of protocols and analyses.
• Provide statistical consultation for clinical programs including design and efficacy assessments.
• Define and manage project timelines for internal and external clients.
• Review and develop SAPs, ADaM specs, TLFs and study deliverables.
• Oversee statistical analyses and data interpretation.
• Interact with Medical Writers and interface with clients/regulatory agencies.
• Mentor Biostatistics staff and develop training materials.
• Present processes and results to clients and stakeholders.

Skills

GCP/ICH/FDA knowledge

Advanced statistics

Time management

Communication skills

Leadership / mentoring

Client engagement

Education

Master's degree in Statistics/Biostatistics or related field

Doctorate degree in Statistics/Biostatistics or related field

Tools

SAS Base

SAS Stat

N-Query

S-Plus

Job description

IQVIA Biotech seeks a Lead Statistician to join its EU Biostats team as a senior leader across oncology drug development. You will provide expert statistical review of SAPs, ADaM specifications and TLFs, ensuring quality and regulatory readiness.

This role requires mentoring biostatisticians across Europe and JPAC, and engaging clients and regulators as a trusted advisor. The position is remote, offering collaboration with an international team and opportunities to shape statistical strategy,