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Associate Director, Clinical Programming

Palo Alto, CA, USA | Jazz Pharmaceuticals

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
    Full-Time
  • Functions:
    Biotech/R&D/Science
    Consulting - IT
  • Experience:
    10-12 years
Job Description:
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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 Clinical Programming will function as the leader of the Clinical Programming group within Clinical Data Management.This position will work collaboratively with data managers, clinicians, trial managers, biostatisticians, and statistical programmers in the planning, conduct, and execution of all phases of clinical studies at Jazz.This position will also develop and maintain a clinical programming infrastructure consistent with and supportive of current and future process developments.


Essential Functions


Lead, manage, coach, develop, and support the Clinical Programming group within Clinical Data Management 

Identify and execute on strategy and enable and ensure the quality of Clinical Programming deliverables

Manage multiple complex projects and assess time and resource estimates/projections for project planning and workflow management for the Clinical Programming group

Understand SAS programming concepts and techniques and other emerging programming tools specific to the pharmaceutical industry and proactively correct limitations in Jazz current strategy

Has excellent SAS Programming skills, and is able and willing to work hands on (study level programming support) if necessary

Create/Update SAS Programming standards, SOPs, and Work Instructions for the programming group as well as for end-users of deliverables as necessary

Represent the Clinical Data Management department in building solid collaborations with cross-functional study and project team members as well as internal and external data-facing stakeholders

Participate in the development and implementation of clinical data standards and lead the development of standard review tools related to clinical data, clinical data review, and risk-based trial management

Required Knowledge, Skills, and Abilities


Excellent verbal and written communication skills across all functional areas.

Excellence in programming with SAS.Knowledge of additional programming languages a plus.

Extensive knowledge of SAS macro writing and usage

Experience as a clinical programmer in supporting data review and trial metrics production

Ability to balance and prioritize multiple assignments and respond quickly to ad hoc requests

Experience with management of direct reports in a corporate environment

Experience leading and implementing strategic improvements in clinical programming preferred

Experience overseeing the work of internal contractors and external vendors (CROs)

Extensive knowledge of CDISC standards, including CDASH and SDTM

Understanding of the drug development process and risk-based trial management concepts

Required/Preferred Education and Licenses


Bachelor’s Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields

Minimum of 10 years of experience in developing and programming software in a clinical trial environment using the SAS system

Minimum of 3 years of supervisory experience

Knowledge of clinical analytics systems a plus

Description of Physical Demands


Occasional mobility within office environment.

Routinely sitting for extended periods of time.

Frequently operating a computer, printer, telephone and other similar office machinery.

Description of Work Environment


Work indoors in a 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.


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