Associate Director - Biostatistics and RWE

Proclinical is currently recruiting for an Associate Director of Biostatistics and Real World Evidence with a leading biopharmaceutical company located in San Francisco, CA. Successful candidate will be responsible for the development of Real-World Evidence (RWE) strategy, and will lead the design and execution of RWE projects for different products, with an initial focus on late phase clinical development and post-marketing safety.

Job Responsibilities:

• Provide technical expertise in epidemiology and biostatistics to develop and maintain a Real-World Evidence strategy to support products from clinical development, through licensing, pharmacovigilance, market access, and lifecycle management.
• Articulate the strengths and limitations of real-world datasets, including disease registries and other clinical data sources, in the context of designing RWD studies.
• Establish real-world data plan, including data licenses and data platforms in collaboration with internal colleagues and external consultants/partners, identify appropriate data sources, obtain access to databases and lead the development of study protocols and analysis plans for RWE projects.
• Ensure the quality, completeness, and relevance of real-world data (RWD) at every step along the way.
• Participate in drug development programs as a subject matter expert (SME) in the areas of RWE.
• Cross-functional collaboration to provide strategic and tactical leadership for developing RWD historical control and methods development.
• Improve disease understanding relevant to the target patient population for key disease areas/initiatives: incidence, prevalence, risk factors, natural history disease course, burden of illness, treatment patterns, co-morbidities, co-medications, outcomes measures, phenotypes, biomarkers and unmet need, and their variations across demographics and geographies.
• Support post marketing activities: Conduct of post marketing post authorization safety studies and post marketing effectiveness studies/registries, epidemiology studies for safety signal detection, evaluation of risk mitigation strategies.
• Proactively monitor and maintain knowledge of global evidence requirements, state-of-the-art RWE research design and the ever-changing landscape of available RWE sources to guide strategic and tactical oversight by using innovative, scientifically robust approaches.
• Identify opportunities for efficient development of innovative research initiatives and application across disease areas. Develop SOPs, guidelines, and templates to support conduct of Real-World Evidence and Epidemiology studies.

Skills and Requirements:

• Bachelor's degree in a statistics discipline is required.
• A PhD in Biostatistics, Epidemiology, Health Economics and outcomes research, or similar is strongly preferred. Equivalent experience may be accepted.
• A minimum of 10 years experience in statistics related to the pharmaceutical industry is required.
• A minimum of 8 years previous management experience is preferred.
• At least 3+ years-experience in observational research study management and data analytics, either within industry or with an observational research consulting firm or academia.
• Extensive knowledge and demonstrated experience with a variety of real-world data sources and observational research study design/execution in biotech/pharmaceuticals, consulting or academia.
• Demonstrated ability to work collaboratively in and lead cross-functional teams.
• Strong project management/organizational skills.
• Self-motivated with the ability to work independently to solve complex and challenging problems using innovative strategies.
• Ability to work well in a business-driven environment, balance priorities and handle multiple tasks through careful planning, stakeholder management, project administration, and organizational skills.
• Excellent interpersonal communication and study management skills.
• Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Felix Hook at (+1) 646-367-2617 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-FH2