Clinical Operations

  • location: South San Francisco, CA
  • type: Contract
  • salary: $45 - $50 per hour

job description

Clinical Operations

Job Title: Clinical Application Specialist II

Position Description

  • Demonstrated practical understanding of SAS programming concepts and techniques.
  • Review output to ensure internal consistency with other output for the activity (CSR, ISS, ISE, )
Position Responsibilities

  • Responsible for the accuracy of SAS programs by reviewing output, reviewing code, reviewing log files and running all checking utilities.
  • Responsible for creating peer review programs for assigned studies.
  • Ensure all SAS programs are imported into the archive system prior to the creation of final output.
  • With supervision, responsible for the creation and accuracy of derivation programs for routine situations, including peer review.
  • With supervision, responsible for the creation and accuracy of submission data sets and analysis programs for routine situations.
  • Responsible for the creation of data definition documents and TOCs.
  • Learn and maintain expertise in the use of the UNIX utilities developed for the Statistical Programmers.
  • Participate in the development of new UNIX utilities.
  • Provide accurate and timely responses to routine requests from clients.
  • Discuss with supervisor to ascertain appropriate understanding of non-routine requests.
Position Requirements

  • SDTM IG v 3.2 or above and ADaM v.1.1
  • Must have oncology experience
  • Experience creating table and graphs from scratch, SG pilot
  • 10+ year of pharma/biotech statistical programming, not clinical programming, experience
  • 5+ year experience in oncology efficacy
  • 5+ year experience in SAS SGPlot
Preferred

  • BLA submission experience is a plus
  • Pinacle 21 experience is a plus
  • Define XML experience with both SDTM and ADaM specs is a plus
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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