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.
The Associate Director of Statistical Programming - will be the
statistical programming lead for all Clinical Data Factory
activities. In this position, the person will work closely with
R&D cross functional team members within Clinical data
management, operations, R&D IT analytics team, clinical
development and biometrics to develop, standardize, maintain and
implement the data transformation and data visualizations. Leads
statistical programming for successful implementation of data
transformation [SDTM, Operational metadata and raw non-EDC] to
support data visualizations and prepare SDT for regulatory
submissions. The Associate Director of Statistical Programming may
have 1-2 direct reports [depends on the growth of pipe line] and
will report into the Head of Statistical Programming, Clinical
Development. This position will support the Execution of Global
Molecule Development-Advance pipeline and build capabilities
* Lead statistical programming for successful implementation of
data transformation [SDTM, Operational metadata and raw non-EDC] to
support data visualizations and regulatory submissions.
* Lead Statistical Programmer on multiple complex projects or
products in the Statistical Programming function, including NDA/BLA
and other submissions to regulatory agencies
* Lead, manage, coach, develop, and support Statistical
Programmers within the Biostatistics Department
* Author or provide input to key study-related documents
produced by other functions (e.g. Statistical Programming Plan,
SAP, CRFs, Data Management Plan, etc.)
* Ensure the quality of Statistical Programming deliverables,
including oversight of CRO biostatistics deliverables
* Collaborate with Stake holders and R&D cross functional
team members within Clinical data management, operations, clinical
development and biometrics to standardize, maintain and implement
the data transformation and data visualization requirements.
* Lead and create data visualization output to enable study
teams to identify trends, safety signals, perform data reviews and
SDTM datasets for regulatory submission.
* Develop custom visualizations based on the best practices of
data standardization and strive to develop standard visualization
shells by Phase and TA of study.
* Develop and maintain KPIs and escalation pathways to ensure
issues are identified, escalated, and prioritized with effective
cross-functional action plans to drive quick resolutions.
* Effectively manage access, risks, and changes by providing
technical guidance, while continuously refining methods and
processes that will improve the end-user experience.
* Create Functional strategies and specific objectives and
develop budgets/policies/procedures to support the functional
* Develop training programs - Train/Mentor programmers on
Clinical Data Systems and mentor peers for the usage of the system
* Participate and/or lead in the development and implementation
of SAS programming standards, SOPs and work instructions, including
program validation and documentation
* Ensure that the filing of study documentation is maintained to
the standard required according to processes and is acceptable for
* Perform/assess time and resource estimates for project
planning, managing timelines for studies/projects
Required Knowledge, Skills, and Abilities
* Thorough knowledge of statistics and the drug development
* Understanding of SAS programming concepts and techniques in
the pharmaceutical industry and ability to correct limitations in
* Ability to manage multiple complex projects and assess
* Excellent verbal and written communication within the
Biostatistics group and across other functional areas.
* Excellent SAS Programming skills, and the ability and
willingness to work hands on (study level programming support) if
* Very strong background in designing visualization tools in a
data visualization environment
* Significant experience in leading SDTM data transformation
using SAS or other ETL tools
* Significant experience with SAS, T-SQL
* Expertise with CDISC standards, specifically CDASH and
* Good understanding on clinical standards as well as clinical
data sets from major EDC systems (e.g., Medidata Rave, INFORM),
safety systems (Argus), and CTMS systems.
* Thorough understanding of clinical data structures, relational
database structures, and data exchange with alternative data
* Knowledge of clinical study design. Detailed knowledge and
experience in CRF design, central laboratories, programming
databases, query resolution, data validation
* In depth understanding of regulatory, industry, and technology
standards and requirements [ICH E6 and Regulatory Guidelines and
* In depth understanding of statistical terminology, clinical
tests, medical terminology, Unblinding of trials and protocol
* Leading change and implementing lean processes, working in
* Strong project management skills; good communication skills;
ability to work in a cross-functional team environment
* Knowledge of R, Python Programming and application of ML is a
Required/Preferred Education and Licenses
* Bachelor or Master's Degree in Statistics, Mathematics, or
related fields; A Master's degree is preferred
* 10 years in a clinical trial/statistical programming role
including 2 years minimum of leadership responsibilities.
Experience as a Lead Programmer overseeing the SDTM activities of
support programmers as well as CRO/external vendors
Description of Physical Demands
* 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
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.