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Associate Director, Statistical Programming

Company: Jazz Pharma
Location: Palo Alto
Posted on: October 16, 2020

Job Description:

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 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

Essential Functions

* 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 infrastructure.

* Develop training programs - Train/Mentor programmers on Clinical Data Systems and mentor peers for the usage of the system and visualizations.

* 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 audit

* 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 process

* Understanding of SAS programming concepts and techniques in the pharmaceutical industry and ability to correct limitations in strategy proactively

* Ability to manage multiple complex projects and assess resource needs

* 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 necessary

* 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 SDTM

* 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 formats

* 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 SDLC]

* In depth understanding of statistical terminology, clinical tests, medical terminology, Unblinding of trials and protocol designs.

* Leading change and implementing lean processes, working in matrix environments

* 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 plus

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 changes.

* 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 demands.

* 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, Palo Alto , Associate Director, Statistical Programming, Other , Palo Alto, California

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