We have an exciting new opportunity for a Biostatistician to join our team in Cambridge, MA. You’ll be part of the ReAl WorLd EvIdence StrateGy and ANalytics (ALIGN) team. In this role you’ll be responsible for providing statistical support and guidance on RWE studies and may serve as the responsible RWE statistician on several RWE projects in different indications.

Primary Responsibilities
• Support cross-function teams in Medical Evidence and Outcomes Research to develop real world evidence generation activities based on RWD sources.
• Design, analyze and report RWE studies in the post-approval setting.
• Implement innovative statistical 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 comparative effectiveness research methods and their implementation
• Increase knowledge of RWD sources (e.g. disease registries and claims)
• Participate in cross-functional initiatives regarding RWE

• Thorough understanding of statistical, pharmacoepidemiology, and outcomes research methods used in RWE studies.
• Experience with secondary data sources including registries, claims data and EMR data.
• 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.
• Experienced with ICH GCP, regulatory (e.g. EMA and FDA) and HTA (e.g. NICE and HAS) guidelines.
• Programming experience with R, SAS or other statistical software packages
• 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.
Qualifications :
Experience working on observational studies.

Education :

MS or PhD in Biostatistics, Epidemiology, Outcomes Research, Economics or equivalent

All your information will be kept confidential according to EEO guidelines.