We have an exciting new opportunity for a Principal Biostatistician of Real World Evidence (RWE) and Personalized Health Analytics (PHA) to join our team in Cambridge, MA. You’ll be part of the Medical Data Science and Analytics (MDSA) team in Personalized Health Research, Analytics and Solutions (PHRAS). In this role, you’ll be responsible for providing biostatistical support and guidance on RWE/PHA studies and may serve as the responsible biostatistician on several projects in different indications.

Primary Responsibilities

• Support cross-function teams in PHRAS to develop real world evidence generation activities based on RWD sources.
• Design, analyze and report RWE/PHA studies in the post-approval setting.
• Implement innovative biostatistical methods with an emphasis on prospective observational study designs and explain their strengths and limitations
• Collaborate with external entities (e.g. thought leaders, academic entities and vendors) in the conduct of RWE/PHA studies
• Support of regulatory submissions, health technology assessments (HTAs) and publications within global, cross-functional teams.
• Increase knowledge of RWE/PHA and indirect (network meta-analysis) methods and their implementation
• Increase knowledge of RWD sources (e.g. disease registries and claims)
• Participate in cross-functional initiatives regarding RWE/PHA

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• MS or PhD in Biostatistics, Epidemiology, Outcomes Research, Economics or equivalent, and an MS with 4-6 years or PhD with 4 years working on observational studies.
• Thorough understanding of biostatistics, pharmacoepidemiology, and outcomes research methods in observational studies.
• Expertise in observational study designs used in pharmacoepidemiology
• Experience with secondary data sources including registries, claims and EMR.
• Good understanding of the communalities and differences between primary and secondary data collection.
• Knowledge of drug development (clinical and post-approval) and understanding drug development as a continuum.
• Programming experience with R, SAS or other statistical software packages
• Experience with ICH GCP, regulatory (e.g. EMA and FDA) and HTA (e.g. NICE and HAS) guidelines.
• Ability to work independently on routine assignments and under little supervision on new assignments.
• Demonstrate strong organizational skills, including the ability to prioritize workload.
• Excellent written and verbal communication skills.

Biogen is looking to hire an experienced Principal Biostatistician to provide valuable support on Real World Evidence (RWE) and Personalized Health Analytics (PHA). The successful candidate can be based out of Biogen's US Headquarters in Cambridge, MA or can be remote.