Principal Statistical Programmer

Jazz Pharmaceuticals

Remote Non Sales-USA, CA

JOB DETAILS
HEADQUARTERS
Remote Non Sales-USA, CA, US
LOCATION
Remote Non Sales-USA, CA
POSTED
15 days ago

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.

The Statistical Programming Group within the Department of Biometrics is responsible for developing software for the analysis of clinical study data in accordance with departmental SOPs and guidelines. 


 

Essential Functions

  • Attend multi-disciplinary team meetings, representing the programming function.
  • Create or review and approve programming plans at study and project level.
  • Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.)
  • Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies.
  • Develop software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies
  • Assist statisticians by suggesting algorithms to address novel analysis requests
  • Develop software validation procedures and test plans, as necessary.
  • Create and document archives of software, outputs, and analysis files.
  • Create and maintain department SOPs related to clinical programming.
  • Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.
  • Oversee work of internal contract programmers and external vendors.
  • Provide time and resource estimates for project planning.

Minimum Requirements

  • Bachelor’s Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; Master’s Degree preferred
  • Minimum of 7 years of experience in developing software for clinical trials using the SAS system 
  • Skilled in programming with SAS.  Knowledge of additional programming languages a plus.
  • Good knowledge of statistics and drug development process
  • Experience as a lead programmer for NDAs/BLAs
  • Experience overseeing the work of internal contractors and external vendors (CROs)
  • Experience in pharmacokinetics/pharmacodynamics modeling a plus
  • Familiarity with CDISC standards, including SDTM and ADaM models
  • Solid verbal and written communication skills

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.

About the Company

Jazz Pharmaceuticals

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing, and commercializing meaningful products that address unmet medical needs.

We have a diverse portfolio of products and product candidates, with a focus in the areas of sleep and hematology/oncology. We also support commercial products in other therapeutic areas where we can meaningfully address serious medical needs.

As part of our unwavering commitment to improve patients’ lives, we are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise. We do this through a growth strategy of growing sales of the existing medicines in our portfolio; acquiring commercial products or product candidates that are in late-stage development; and pursuing focused development of our pipeline of differentiated therapies.

COMPANY SIZE
10,000 employees or more
INDUSTRY
Medical Devices and Supplies
FOUNDED
2003
WEBSITE
https://www.jazzpharma.com/