SAS Programmer (Contract)

Amicus Therapeutics, Inc. Cranbury, NJ
SAS Programmer (Contract)

Summary of Position

The Statistical Programmer is responsible for leading the statistical programming activities within Amicus. Filling this need will increase Amicus' productivity to meet development needs, enhance efficiencies, reduce cost and ensure consistent quality across projects through formal processes

Roles and Responsibilities

* Participating in project team meetings to ensure timelines are met with high quality

* Performing quality control of SDTMs to ensure submission requirements are met.

* Create and be able to perform quality control of ADaMs to ensure submission requirements are met

* Performing quality control of ISE/ISS datasets, tables, figures and listings with quality within the timeline.

* Communicating effectively internally with the project team members and externally with various vendors.

* Performing ad-hoc analyses for in-house request or QC of such analyses under tight timelines

* Support database build and other data management programming activities

* Leading effort in building in-house programming tools and macros

Qualifications and Background Requirements

* Minimum educational experience is a BS in computer science, mathematics, statistics or related analytic field.

* Preferred educational experience is a Master's degree in Statistics/Biostatistics in the biopharmaceutical industry, with knowledge of biomedical sciences

* Minimum of 5-6 years of SAS programming and application development experience in pharmaceutical/biotech company

* Thorough knowledge of functional areas within the clinical development organization including but not limited to clinical operations, data management, statistics, medical writing and regulatory affairs.

* Deep understanding of the statistics/data management role in the broader clinical development setting

* Solid, hands-on knowledge of the use of statistical software (e.g., SAS or SAS Jump including SAS/GRAPH, and SAS/STAT), including report generation is necessary.

* Prior work experience in the CDISC SDTMs and ADaMs is a must.

* Prior experience in electronic NDA/BLA submissions via eCTD and responding to FDA/regulatory requests

* Strong MS Office skills (Word, Excel, PowerPoint), and skills in generating graphs and figures.

* Excellent verbal and written communication and interpersonal skills.

* Demonstrated ability to work in a team environment.

* High degree of motivation; results oriented.

Travel

* 0-5%