Senior Manager, Sr. Statistical SAS Programmer

San Francisco, CA 94104

Posted: 06/17/2019 Employment Type: Contract-to-Hire Industry: Clinical & Scientific Job Number: 15910
Senior Manager, Senior Statistical SAS Programmer
San Francisco, CA

 

Reporting to the Associate Director, Statistical Programming the Senior Manager, Senior Statistical SAS Programmer will perform data analysis using primarily the SAS programming language for interpretation of clinical trial data.   AAV Gene Therapy is an innovative, and potentially transformative way of treating severe, genetic diseases. The position will be based in our San Francisco Offices. Working in this ultra-rare indication environment and in this capacity, some of the biggest interpersonal and technical challenges are the following:

 

The specific responsibilities of this position include:
  • Independently program CDSIC SDTM, ADaM datasets and to ensure submission requirements are met
  • Develop define.xml and RGs for submissions
  • Develop Tables, Listing and Figures per the SAP, DMC, or annual Safety report specifications
  • Validate and QC SAS programs as needed
  • Provide validation support for programming tasks that are required for posters and publications
  • Work on multiple tasks and prioritize tasks to meet the needs
  • Understands importance of timelines and strives to meet them at all times
  • Proven ability to prioritize tasks, delegate or escalate as needed
  • Able to operate in a validated 21CFR Part-11 compliant environment

 

Required Education, Skills and Experience
  • B.S. degree in computer science, statistics, mathematics or related areas and 6+ years of direct and related experience in pharmaceutical and biotechnology industry and 2+ years’ experience as a Manager or Senior Manager
  • A very clear and proven hands-on experience with safety annual reports, integrated analyses – familiarity with IND/BLA electronic submission requirements is a plus
  • Proven ability to write cross-referencing check programs as needed
  • Familiarity with CDISC Standards including SDTM and ADaM

 

 
  • Strong SAS programming skills including macros and statistical procedures
  • Strong experience with SAS GRAPH and ODS output
  • Successful history and experience with CDISC standards and development
  • Excellent understanding of clinical trials and regulated and GCP compliant working environment
  • Excellent oral and written communication skills
  • Demonstrated positive attitude, able to follow instructions and always reliable
  • Proven ability to adapt to change
  • Ability to work independently as well as collaboratively
  • Desire to be creative and proactive
  • A strong collaborator with a proven ability to build professional relationships, with internal and external partners
  • Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks, timelines, and priorities efficiently and effectively
  • Commitment to core values: Be BOLD, Care deeply, and #GetStuffDone

 

Preferred Skills and Experience
  • Familiarity with rare indication

 
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