Principal Statistical Programmer (Remote)
Company: Disability Solutions
Location: Philadelphia
Posted on: April 18, 2024
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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 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
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 lawJazz
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, Bel Air North , Principal Statistical Programmer (Remote), IT / Software / Systems , Philadelphia, Maryland
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