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Join to apply for the Associate Director, Biostatistics (FSP - Permanent Homebased) role at Nanosep AB

Job Overview

As an Associate Biostatistics Director, you will liaise with cross-functional teams to drive quality statistical planning, analysis, and reporting in support of pharmaceutical development and regulatory submissions. You will serve as a resource for the department, ensuring scientific integrity and regulatory compliance in applying statistical methodology to clinical trials. Your responsibilities include leading major projects, contributing to clinical development plans, reviewing protocols, analysis plans, and reports, and responding to regulatory queries.

Leadership

Key Responsibilities:

• Serve as a biostatistical consultant for department members and staff from other Biostatistics departments.
• Represent sponsors at regulatory meetings and participate as a Data and Safety Monitoring Committee member.
• Engage in research activities, teaching, presentations, and manuscript preparation.
• Lead studies operationally and review statistical standards and validation procedures.
• Consult on operational, statistical, and therapeutic topics.

Knowledge Sharing

Maintain awareness of developments in biostatistics, clinical trial methodology, and regulatory requirements. Act as a subject matter expert (SME).

Risk Management

Identify and mitigate risks to project delivery and quality, supporting escalation and risk mitigation actions.

Lock And Unblinding Process

Lead the database lock and unblinding process; draft randomization specifications and perform quality control reviews.

Statistical Expertise

Provide expert input on statistical review of deliverables, data management, and review of ADaM guides. Perform senior biostatistical review and quality control of sample size calculations.

Requirements

• Masters or PhD in Biostatistics or related field with 10+ years relevant experience.
• Expertise in complex statistical methods for Phase 2-3 trials.
• Experience as a statistical lead for regulatory submissions.
• In-depth knowledge of GCP, ICH guidelines, SAS or R, and CDISC standards.
• Strong communication, collaboration, and problem-solving skills.
• Experience in rare diseases and immunology is preferred.

IQVIA is a global provider of clinical research services, commercial insights, and healthcare intelligence. We aim to accelerate medical development and improve patient outcomes worldwide. Learn more at https://jobs.iqvia.com.

We value diversity and are committed to inclusion. Join us in our mission to improve health outcomes globally.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Science