We have an exciting new opportunity for a Real World Evidence (RWE) Principal Biostatistician to join our team in Cambridge, MA. You’ll be part of the Real World Evidence Strategy and Analytics team in Medical Evidence Research and Innovation (MERI). In this role, you’ll be responsible for providing biostatistical support and guidance on RWE studies and may serve as the responsible RWE biostatistician on several RWE projects in different indications.
Support cross-function teams in MERI to develop real world evidence generation activities based on RWD sources.
Design, analyze and report RWE 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 studies
Support of regulatory submissions, health technology assessments (HTAs) and publications within global, cross-functional teams.
Increase knowledge of RWE 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
Qualifications / Skills
Thorough understanding of biostatistics, pharmacoepidemiology, and outcomes research methods in RWE 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.
MS or PhD in Biostatistics, Epidemiology, Outcomes Research, Economics or equivalent, and an MS with 4-6 years or PhD with 2-4 years working on observational studies.
Internal Number: BIIB012019
Biogen (NASDAQ: BIIB) is a biotechnology leader in the neurosciences that discovers, develops and delivers innovative therapies to improve the lives of patients. As a company, Biogen recognizes that cutting-edge science and medicines can change the course of devastating diseases.