Statistical Analyst - ADaM Programming (Hybrid)
About The Position
The Statistical Analyst is an integral contributor to the research and development of new pharmaceutical products. The role analyzes and reports clinical trial data independently for routine activities and with supervision for more complex activities. It interfaces with Statistics, Clinical Data Strategy & Operations, and Development Operations. The analyst leads statistical programming activities for routine studies, creates documentation for regulatory filings, contributes to the development and communication of standard SAS macros, and produces data visualizations. The role also develops and validates SAS programs and ADaM datasets, tables, listings, and figures according to CDISC standards, and creates specifications for study-level and integrated ADaM datasets.
Requirements
- A master’s degree in Statistics, Computer Science, or a related field and at least 2 years of relevant experience, or a bachelor’s degree in one of these fields and at least 4 years of relevant experience.
- Experience in pharmaceutical clinical trials.
- Demonstrated practical understanding of SAS programming related to drug development.
- Experience creating and reviewing ADaM datasets for analysis.
- Ability to communicate clearly, both orally and in writing.
- Basic understanding of CDISC standards.
- Basic understanding of the drug development process.
Nice To Haves
- Demonstrated ability to support efficacy analyses across clinical development phases and therapeutic areas.
Responsibilities
- Lead statistical programming activities for routine studies.
- Create documentation for regulatory filings, including reviewers’ guides and data definition documents.
- Participate in developing standard SAS macros and present information on existing macros.
- Produce dynamic and static data visualizations to communicate quantitative analyses.
- Develop SAS programs to create ADaM datasets following CDISC standards.
- Develop SAS programs to create tables, listings, and figures.
- Validate ADaM datasets.
- Validate tables, listings, and figures.
- Create specifications for the structure of ADaM datasets for individual studies and integrated data.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
