Conduct high-quality statistical programming including developing and maintaining SAS programs tailored to clinical development programs' needs.
Generate SDTM domains and Adam datasets.
Generate tables, figures, and listings as described in statistical analysis plans.
Provide statistical programming support to exploratory analyses both internally and in response to regulatory agencies' ad-hoc requests.
Participate in the development of CRFs, edit check specifications, and data validation plans.
Define and maintain data repository folder contents associated with statistical programming.
Review SOPs and/or Work Instructions related to statistical programming practices.
Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc) to ensure meeting project timelines and goals.
Oversee statistical programming contractors.
Requirements:
BA/BS degree in mathematics, science or health related field.
Minimum 5 years of programming experience using SAS.
Base/Stat/Macro/GRAPH in the biopharmaceutical and/or CRO industries; a MS
Data Management experience and knowledge of CDISC standard are
Good SAS programming skills and attention to detail are
Demonstrate knowledge of regulatory biostatistics, SOPs, and Highly motivated and able to work well independently.
Strong organizational, time management, communication and project coordination and leadership skills.
Must be able to work well under timeline pressure.
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