Description
A pharmaceutical company in the San Francisco Bay Area with an extremely innovative approach to Clinical Research is actively seeking a Principal SAS Programmer. This company has a very strong pipeline and three products already on the market. All team members are passionate and excited by their work, created a thriving and vibrant company culture.Position Description:
- Assist in the review of key study-related documents produced by other functions, e.g. SAP, case report form, data management plan, database specifications, EDC data structures, DMC plans and other clinical documents.
- Write, test and validate SAS programs to produce analysis datasets, TLGs and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
- Write CDSIC standard dataset specifications and follow specifications to create SDTM and ADAM datasets.
- Understand and execute department-, product- and study-level macros and utilities. Write, test and validate product- and study-level macros and utilities.
- Provide input to and participate in intra-departmental meeting.
- Assist in the review of Statistical Programming policies, standard operating procedures and other controlled documents.
- Provide support to and mentor junior programmers and contractors
- Attend external professional organizations, conferences, training and/or meetings
Requirements:
- 6-8 years clinical research and development programming experience
- Masters in Statistics
- Extensive hands-on experience in CDSIC standards and datasets (SDTM, ADAM)
- Experience in Oncology Trials
- Experience in FDA/EMEA trial submissions
- Drug Development (pre-, early, late and/or observational) in related industries or academic research
- Computer programming using SAS
This is an amazing opportunity at a company with a truly inspiring and motivating culture.
To find out more about Real please visit www.realstaffing.com