About the Company

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science with unparalleled patient support systems to improve people's lives. The company has strong market positions in neurodegenerative diseases, MS and endocrinology. EMD Serono is also a leader in fertility treatments. With a clear focus on the patient and a leadership presence in the biopharmaceutical industry, EMD Serono's US footprint continues to grow, with more than 1000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.

Description

• Independently program (or write validation programs for) and document tables/listings/graphs for clinical trials or portions of clinical trials requiring routine data manipulation and analysis.
• Routine data manipulation and analysis with limited direction
• Program (or write validation programs for) and document tables/listings/graphs for clinical trials requiring complex data manipulation and analysis.
• Provide input into general standardization efforts and create (or validate) global macros that streamline repetitive operations.
• Mentor biostatisticians and statistical programmer/analysts with advance SAS programming techniques.
• Interface with SAS technical support to resolve software problems.
• Coordinate, validate and implement SAS upgrades and licenses.
• Independently provide input into CRF specifications to collect data specified in the protocol and query with SAS technical support to resolve software problems, coordinate, validate and implement SAS upgrades and licenses.
• Independently provide input into CRF specifications to collect data specified in the protocol and query check specifications and provide input into analysis plan specifications and data presentations for clinical trials requiring complex data manipulation and analysis.
• Independently program (or write validation programs for) patient randomizations.
• Independently create (or validate) non-standard complex derived datasets.
• Create project and study phase sub-directories ensuring that all project work resides in the corret project and study phase sub-directories.
• Validate study phase flags in oracle tables and download study phase records from oracle tables to create analysis datasets.
• Audit changes to the database between study phases.
• Understand and follow all statistical and statistical programming SOP’s as well as any other relevant SOP.
• Lead process improvement teams as required.
• Effectively communicate analysis specification and programming/data issues that arise prior to or during analysis in a timely manner.