Associate Director, Real-World Data, Measurement, and Analytics

Position Summary:

The Associate Director of Biostatistics for Real-World Data, Measurement, and Analytics (RWDMA) will be instrumental in driving real-world data (RWD) projects and initiatives. This role requires providing biostatistical expertise and supporting methodological innovation to enhance the development and commercialization of pharmaceutical products. Collaborating closely with stakeholders in R&D and Medical Affairs, the Associate Director will design and analyze RWD studies using cutting-edge biostatistical methodologies associated with causal inference and comparative effectiveness, digital measurement, clinical outcomes assessment, longitudinal and predictive modeling, and evidence synthesis.

Key Responsibilities:

Biostatistical and Methodologic Support:

• Lead and oversee the execution of real-world studies, ensuring methodological rigor and regulatory adherence.

• Create and refine statistical analysis plans, conduct complex statistical analyses, and convey findings to internal and external stakeholders.

• Apply advanced statistical methods tailored to specific study objectives, ensuring robust data interpretation and insight generation.

• Engage in strategic communication initiatives to effectively promote and disseminate biostatistical deliverables both within the organization and to external stakeholders.

• Promote an innovative and collaborative environment that encourages knowledge transfer and continuous learning within the team.

Project Leadership and Collaboration:

• Serve as the statistical leader on assigned projects, managing timelines, resources, and deliverables to meet project goals.

• Collaborate effectively with clinical, RWD, regulatory, data management, and programming teams to ensure statistical strategies align with overarching project goals.

• Provide statistical expertise in interactions with regulatory bodies, including meeting preparations, query responses, and submission support.

• Act as a subject matter expert in statistical methodology, delivering insights and guidance to support organizational decision-making.

Methodological Development and Innovation:

• Stay informed on industry trends and incorporate emerging biostatistical methods to enhance study designs and analytics.

• Participate in methodological research, contributing to the development of analytical techniques and addressing statistical challenges.

Regulatory Support and Compliance:

• Provide biostatistical expertise during regulatory submissions, meeting preparations, and addressing queries to ensure alignment with regulatory standards.

• Contribute as a subject matter expert, offering statistical guidance for organizational decision-making processes.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Ph.D. in Biostatistics, Statistics, Epidemiology or a related field with 6+ years’ experience in the pharmaceutical, biotechnology, or healthcare industry, focusing on real-world data analytics.

• Experience in advanced biostatistical methods, including those associated with causal inference and comparative effectiveness, longitudinal and predictive modeling, precision medicine and evidence synthesis.

• Experience with statistical programming languages (e.g., R, Python) and applied experience with observational data.

• Experience with regulatory requirements for clinical trials and real-world data analysis.

• Previous leadership in managing or leading statistical projects, delivering high-quality results in a dynamic environment.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Experience in methodological research with contributions to publications in real-world data analytics.

• Experience using artificial intelligence and machine learning methods in real-world data applications.

• Excellent communication skills, with the ability to effectively convey complex statistical concepts to a variety of stakeholders.