Company: Jazz Pharma
Posted on: November 10, 2019
Overview:Jazz Pharmaceuticals is an international biopharmaceutical
company focused on improving patients? lives by identifying,
developing and commercializing meaningful products that address
unmet medical needs. We are continuing to expand our commercial
product portfolio and our research and development pipeline in
therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and
hematology/oncology ? areas in which we have a deep understanding
of the patient journey and a suite of products and product
candidates to address critical needs.
We are looking for the best and brightest talent to join our team.
?If you?re looking to be a part of a company with an unwavering
commitment to improving patients? lives and being a great place to
work, we hope you?ll explore our career openings and get to know
Jazz Pharmaceuticals.?Responsibilities:The Manager, Biostatistics
(Medical Affairs) will be functioning as a project level
statistician. The role is responsible for developing, coordinating,
performing, and validating all statistical analyses in support of
Medical Affairs, inclusive of overseeing the work of statistics and
programming for external vendors as needed.This opportunity is
available in both Palo Alto, CA and Philadelphia, PAEssential
- Work collaboratively with other members of the Medical Affairs
team to develop and provide scientifically sound analyses that
answer questions to support and enhance publications and knowledge
of Jazz Pharmaceuticals products.
- Participate in Publication Planning Meetings as a Biostatistics
representative; contribute to publication planning including
timelines, statistical and analytical requirements for
publications, projects, and publications plans.
- Develop, design, and oversee or perform post-hoc analyses of
existing databases and meta-analyses as needed and appropriate
- Support clinical development biostatistics with exploratory
analyses necessary for submissions and regulatory queries.
- Review publications, marketing materials, and education and
training materials that contain clinical data and product
- Stay informed with data being generated in current clinical
- Manage CROs regarding statistical activities to ensure timely
delivery of quality analysis results as necessary
- Provide guidelines and standards to CROs to ensure quality of
- Provide support for approval for payers at the country
level.Required Knowledge, Skills, and Abilities
- Proficient in US drug development regulations pertinent to
- Proficient SAS programming skills, solid understanding of CDISC
SDTM and ADAM models and standards
- Excellent writing and communication skills
- Travel 10-20%.Required/Preferred Education and Licenses
- MS, MPH, or PhD in statistics, mathematics, or related field,
with 4+ years (MS/MPH) or 2+ years (PhD) experience
- Experience supporting Medical Affairs/publication of analysis
results (e.g. abstracts, posters, manuscripts) a plusDescription of
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other
similar office machinery.Description of Work Environment
- Work indoors in normal office environment with little exposure
to excessive noise, dust, fumes, vibrations and temperature
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include
working outside of ?normal? work hours, in order to meet business
- Occasional public contact requiring appropriate business
apparel.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.
Keywords: Jazz Pharma, Camden , Biostatistics Manager, Executive , Camden, New Jersey
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