Senior Biostatistician in RWE

POSITION SUMMARY

The Senior, Biostatistician Real-World Evidence will be responsible for developing a strategy to enhance research capabilities, as well as to lead the development and implementation of research projects that further expand our understanding of hematologic diseases and care. The Senior Manager organizes, manages, and executes the strategy that includes promoting high quality extramural research projects, driving a research agenda through the development of an intramural research program, and connecting and maintaining relationships with federal regulators to ensure ASH RC real-world evidence (RWE) strategy aligns with regulatory changes.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Oversee the process for evaluating research proposals with member leaders of ASH RC to assess study s scientific merit, feasibility, and impact.
• Evaluate research proposals for Data Hub data from external parties.
• Ensure alignment of RWD and RWE efforts across the Data Hub.
• Contribute to the design of data acquisition to ensure data captured supports ASH RC s research priorities.
• Execute data quality assessments to inform the development and ongoing work involved with the Data Hub s Data Quality Strategy.
• Support the Deputy Director in the execution of the ASH RC s Real-World Evidence Consortium.
• Develop and disseminate study findings through conference presentations, posters, and collaborative development of manuscripts.
• Support enhancements of the Data Hub through improvements and linkages to other data sources.
• Provide statistical and translational research expertise in the design of prospective real-world research studies.
• Manage and support data projects that involve statistical analysis both internally and externally to ASH RC.
• Maintain strong relationships with federal regulators to ensure the RWE strategy aligns with regulatory changes.
• Collaborate with the Director, Strategy and Business Development to support industry-sponsored usage of the Data Hub.
• Oversee the execution of industry-sponsored usage of Data Hub data.
• Lead the application of state-of-the-art statistical methods to conduct analyses to address research questions using data from the Data Hub.

QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED

• Doctoral degree in Biostatistics, Statistics, Epidemiology, or a related field is preferred or Masters-level experience with a minimum of 7 years.
• Experience with registries or other large observational data sets.
• Proficiency in working with large datasets involving electronic health record data and constructing clinical concepts using EHR code sets.
• Proficiency in statistical software such as SAS and knowledge of Python, R, and SQL.
• Experience with the design of longitudinal observational clinical studies and analytic methods for causal inference.
• Experience in developing and nurturing the strategic direction for a RWE generation program.
• Experience with decentralized trial design is preferred.
• Excellent communication and interpersonal skills to effectively collaborate with internal teams, external partners, and regulatory bodies.
• Comprehensive understanding of healthcare compliance and regulatory requirements with a special emphasis on HIPAA.
• Strong problem-solving skills and the ability to manage multiple projects simultaneously.
• Ability to stay current with advancements in RWE methodologies and regulatory requirements.

ASH has a hybrid work environment, with core in-office days for all ASH staff on Tuesdays, Wednesdays, and Thursdays, and telework on Mondays and Fridays for eligible positions. The Society s headquarters is in Washington, DC, and is within walking distance of several Metro stations on the Blue/Orange/Silver and Red lines.

The American Society for Hematology (ASH) is an equal opportunity employer that is committed to diversity, equity, and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, age, sexual orientation, gender identity or expression, national origin, disability, genetic information, pregnancy, veteran status, or any other protected characteristic as outlined by applicable federal, state, or local laws.