Job Description

Responsibilities:

• 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 standards.
• Good SAS programming skills and attention to details.
• Demonstrate knowledge of regulatory biostatistics, SOPs
• 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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