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Principal Biostatistics, Medical Affairs

Company: Jazz Pharmaceuticals
Location: Philadelphia
Posted on: October 14, 2021

Job Description:

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Principal, Biostatistics

The Principal, Biostatistics (Medical Affairs) will be functioning as a project level statistician. The role is responsible for developing, coordinating, performing, and validating all statistical analyses in support of Medical Affairs, inclusive of overseeing the work of statistics and programming for external vendors as needed.

This opportunity is available in both Palo Alto, CA and Philadelphia, PA

Essential Functions

  • Work collaboratively with other members of the Medical Affairs team to develop and provide scientifically sound analyses that answer questions to support and enhance publications and knowledge of Jazz Pharmaceuticals products.
  • Participate in Publication Planning Meetings as a Biostatistics representative? contribute to publication planning including timelines, statistical and analytical requirements for publications, projects, and publications plans.
  • Develop, design, and oversee or perform post-hoc analyses of existing databases and meta-analyses as needed and appropriate
  • Support clinical development biostatistics with exploratory analyses necessary for submissions and regulatory queries.
  • Review publications, marketing materials, and education and training materials that contain clinical data and product claims
  • Stay informed with data being generated in current clinical development programs
  • Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results as necessary
  • Provide guidelines and standards to CROs to ensure quality of deliverables
  • Provide support for approval for payers at the country level.

Job Requirements:

  • Master’s degree with  > 2 years of experience; OR PhD with no experience in Statistics, Mathematics, or related fields
  • Experience supporting Medical Affairs/publication of analysis results (e.g. abstracts, posters, manuscripts) a plus
  • Proficient in US drug development regulations pertinent to statistical analysis
  • Proficient SAS programming skills, solid understanding of CDISC SDTM and ADAM models and standards
  • Excellent writing and communication skills
  • Travel 10-20%.

Description of Physical Demands

  • Occasional mobility within office environment.
  • Routinely sitting for extended periods of time.
  • Constantly operating a computer, printer, telephone and other similar office machinery.

Description of Work Environment

  • Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
  • Frequent computer use at workstation.
  • May move from one work location to another occasionally.
  • Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
  • Occasional public contact requiring appropriate business apparel.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

Keywords: Jazz Pharmaceuticals, Philadelphia , Principal Biostatistics, Medical Affairs, Other , Philadelphia, Pennsylvania

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