Principal Statistical Programmer (Remote)
Company: Disability Solutions
Location: Carlsbad
Posted on: April 19, 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. rief
Description:The Clinical Data Integration and Standards (CDI&S)
group is accountable for data engineering and data pipeline
activities within the Integrated Data Analytics and Statistical
Programming (IDASP) group, primarily involving SDTM transformations
for clinical trial and real-world data.The Principal Statistical
Programmer provides Statistical Programming project and technical
leadership on CDI&S projects, and supports other CDI&S team
members. They are responsible for the development and quality of
all aspects of CDI&S deliverables on their assigned projects in
accordance with departmental SOPs and guidelines. They delegate
tasks appropriately and track progress. The Principal Statistical
Programmer may also construct estimates of project resource
requirements and timelines and routinely briefs management on
accomplishments, status of projects, and any issues.Essential
Functions/Responsibilities
- Attend multi-disciplinary team meetings, representing the
CDI&S function.
- Create or review and approve statistical programming plans at
study and project level.
- Provide input on key study-related documents produced by other
functions (e.g. CRFs, Data Management Plan, etc.).
- Create or review and approve CDISC-compliant datasets and
corresponding documentation for electronic submission to regulatory
agencies.
- Implement in-house data standards.
- Develop software validation procedures and test plans, as
necessary.
- Create and document archives of software, outputs, and analysis
files.
- Create and maintain department SOPs and guidelines related to
clinical programming.
- Oversee work of internal contract programmers and external
vendors.
- Provide time and resource estimates for project
planning.Required Knowledge, Skills, and Abilities
- Minimum of 7 years of experience in developing software for
clinical trials using the SAS system. Experience in real-world data
a plus.
- Skilled in programming with SAS. Basic knowledge of additional
programming languages such as R or Python.
- Good knowledge of statistics and general drug development
processes. Basic knowledge of the Oncology drug development process
and data structures is a plus.
- 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.
- Expert knowledge of SDTM and Define-XML standards. Knowledge of
CDASH and ADaM a plus.
- Solid verbal and written communication
skills.Required/Preferred Education and Licenses
- Bachelor's Degree in Computer Science, Statistics, Mathematics,
Life Sciences or other relevant scientific fields; Master's Degree
preferred.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 anticipated base pay range is $128,000-$168,000. The
exact base pay offered for this role will depend on various
factors, including but not limited to the candidate's
qualifications, skills, and experience.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, San Marcos , Principal Statistical Programmer (Remote), IT / Software / Systems , Carlsbad, California
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