General Summary:
The Real World Statistician will serve a statistics role on assigned projects including real world observational studies, market access and reimbursement activities, clinical trials, and other ad hoc analyses conducted by Global Medicines Development and Affairs, and Commercial and Strategic Management. The individual will complete assigned work in a resourceful, self-sufficient manner, and should possess a good knowledge of related disciplines while performing statistics activities with a drug developer mindset.
Key Duties and Responsibilities:
• Responsible for all scientific and operational statistical work for assigned observational studies, real world data investigations, or clinical trials. Performs critical review of study protocols including study design and analysis methods, performs critical review of data and analysis results, conduct statistical analysis, and undertakes new and complex issues with some mentoring and guidance.
• Participates in regular Study Execution Team meetings, representing Real World Statistics as a member of cross functional teams, providing strategic input and expert technical guidance to team members.
• Effectively collaborates with multiple stakeholders from Health Economics and Outcome Research, Medical Affairs, Clinical Development and Real World Evidence teams.
• When needed, supports development of study documents owned by Statistics such as Cross-functional Data Review plan, Key Results Memo, and Data Dissemination Plan in order to facilitate the review, summary, and dissemination of key study data/results.
• When collaborating with statistical programming for deliverables, provides input into the programming specifications and perform critical review. Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with high quality.
• Contributes to study reports, publications, and related processes.
Knowledge and Skills:
• Demonstrated ability to design and analyze observational studies with knowledge of US healthcare system, health insurance billing data, and electronic medical record data.
• Strong programming skills; familiarity with data analysis methods.
• Ability to work effectively in a constantly changing, fast-paced, diverse, and matrix environment.
• Ability to multitask; strong work ethic and a “can-do” mentality.
• Ability to show critical thinking with logical problem-solving.
• Excellent written and verbal communication skills.
• Excels in a team environment.
• Collaborates well with non-statisticians.
Education and Experience:
• PhD or Master degree in Biostatistics or related fields with 3 to 7 years of relevant work experience.
• Minimum 2 years of experience working on observational studies within the life sciences industry, government, or consulting environment. Pharma/Biotech experience highly desired.
• 3 years SAS and R programming experience is required.
