Principal Statistical Programmer (Remote)
Company: Jazz Pharmaceuticals
Location: Sharon Hill
Posted on: May 3, 2024
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Job Description:
If you are a Jazz employee please apply via the Internal Career
site
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.
Brief Description:
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
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.
FOR US-BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable
compensation practices and we strive to provide employees with
total compensation packages that are market competitive.
For this role, the full and complete base pay range is
$128,000-$192,000. Individual compensation paid within this range
will depend on many factors, including qualifications, skills,
relevant experience, job knowledge, and other pertinent factors.
The goal is to ensure fair and competitive compensation aligned
with the candidate's expertise and contributions, within the
established pay framework and our Total Compensation philosophy.
Internal equity considerations will also influence individual base
pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation
package. The successful candidate may also be eligible for a
discretionary annual cash bonus or incentive compensation
(depending on the role), in accordance with the terms of the
Company's Global Cash Bonus Plan or Incentive Compensation Plan, as
well as discretionary equity grants in accordance with Jazz's Long
Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in
various benefits offerings, including, but not limited to, medical,
dental and vision insurance, 401k retirement savings plan, and
flexible paid vacation. For more information on our Benefits
offerings please click here:
https://careers.jazzpharma.com/benefits
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Keywords: Jazz Pharmaceuticals, Bethlehem , Principal Statistical Programmer (Remote), IT / Software / Systems , Sharon Hill, Pennsylvania
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