Associate Director, Medical Writing
Category: Research & Development | Country: United States | State: Pennsylvania | City: Philadelphia | Type: Regular, Full Time | Job ID: 4599
Same job available in two sites
Philadelphia, Pennsylvania, United States
Palo Alto, California, United States
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 haematology/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 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, PA
- 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 claims
- Stay informed with data being generated in current clinical development programs
- 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 deliverables
- Provide support for approval for payers at the country level.
- 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 plus
- Proficient in US drug development regulations pertinent to statistical analysis
- Proficient SAS programming skills, solid understanding of CDISC SDTM and ADAM models and standards
- Excellent writing and communication skills
- Travel 10-20%.
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.