Senior Statistical Programmer (Remote/Home Based)
Company: Disability Solutions
Location: Palo Alto
Posted on: May 6, 2024
Job Description:
If you are a Jazz employee please apply via the Internal Career
siteJazz 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 Integrated Data Analytics and Statistical
Programming Group (IDASP) within the Department of Data sciences 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.
- Oversee work of internal contract programmers and external
vendors.
- Create or review for accuracy, any reviewer guides and
define.xml documents for clinical data packages.
- Writes and/or implements specifications and oversees
completeness of relevant documentation.Minimum Requirements
- Bachelor's Degree in Computer Science, Statistics, Mathematics,
Life Sciences or other relevant scientific fields; Master's Degree
preferred
- Minimum of 3 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 skillsJazz
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 ONLYJazz 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 $108,000-$162,000. 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:
Keywords: Disability Solutions, North Highlands , Senior Statistical Programmer (Remote/Home Based), IT / Software / Systems , Palo Alto, California
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