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Principal Programmer- Pharmacometrics

Company: Intercept Pharmaceuticals
Location: San Diego
Posted on: March 18, 2019

Job Description:

Job Description:

COMPANY SUMMARY:

At Intercept, our mission is to build a healthier tomorrow for patients with progressive non-viral liver diseases.

Intercept's lead product, Obeticholic Acid (OCA), is a potent first-in-class farnesoid X receptor (FXR) agonist. OCA, marketed under the brand name "Ocaliva," is approved in the U.S., EU and Canada for use in primary biliary cholangitis (PBC), a rare autoimmune liver disease. OCA is also being investigated as a treatment for nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).

In February 2019, Intercept reported positive topline results from the Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to NASH. REGENERATE is the first and largest Phase 3 study in NASH - a chronic disease that threatens the lives of millions of people in the U.S. alone. By 2020, NASH is expected to overtake hepatitis C as the leading cause of liver transplants in the U.S. Currently, there are no available treatments for NASH, and Intercept is among the leading companies focused on the disease.

Based on the positive results from REGENERATE, Intercept intends to file for regulatory approval in the U.S. and EU in the second half of this year. This is an exciting time for Intercept, as the organization prepares for a potential approval and launch in NASH. As part of this effort, Intercept is beginning to build a new commercial organization, and this opportunity in Talent Acquisition will play a pivotal role in preparing the company for the successful launch of OCA's second indication.POSITION SUMMARY:This essential team member will be responsible for supporting the pharmacometric programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs. As part of the Pharmacometrics team, this person will also provide technical expertise to the development of SAS programming standards and procedures related specifically to pharmacometric analyses.ESSENTIAL FUNCTIONS:To perform this job successfully an individual must be able to perform each essential function satisfactorily.


  • Generate, validate, and/or review figures and tables to support the pharmacometric analysis of clinical trials data in support of regulatory submissions and publications
  • Contribute to written programming/dataset/analysis plans for pharmacometrics projects
  • Generate, validate, and/or review analysis-ready datasets and associated specifications.
  • Generate or perform quality control for SAS programs and other study documents (e.g., presentations and reports)
  • Maintain complete and auditable documentation of all programming activities
  • Review datasets and output across SAS programs and studies to ensure consistency
  • Provide pharmacometric programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
  • Participate in the development and/or maintenance of departmental procedures and standards
  • Adhere to departmental and regulatory agency procedures and standards
  • Generate and/or review define.pdf documents
  • Work effectively with cross functional groups, study team, and vendors
  • May supervise more junior pharmacometric programmers as necessary
  • Other duties as assigned


    Required Experience:QUALIFICATIONS:


    • Bachelor's degree in Statistics, Mathematics, or Computer Science or in a related field
    • Minimum of 6 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer
    • Extensive knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS
    • Extensive knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
    • Excellent organizational skills, time management, and ability to meet established deadlines
    • Excellent communication and interpersonal skills to effectively interface with others
    • NDA submission experience is a must

      REQUIRED KNOWLEDGE AND ABILITIES:


      • Strong verbal and written communication skills are essential
      • Excellent organization and multi-tasking skills
      • Exceptional interpersonal skills and problem solving capabilities
      • Ability to work effectively across a matrix organization
      • Ability to work independently and collaboratively
      • Ability prioritize with minimal daily instruction
      • Ability to think strategically in order to improve current processes


        Keyword: Principal Programmer- Pharmacometrics

        From: Intercept Pharmaceuticals

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        Keywords: Intercept Pharmaceuticals, San Diego , Principal Programmer- Pharmacometrics, IT / Software / Systems , San Diego, California

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