Manager, Statistical Programming - Medical Affairs
Posted on May 14, 2019 by Jazz Pharma
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 Medical Affairs Statistical Programming Group within the Department of Biostatistics is responsible for developing software for the analysis of clinical study data for the Medical Affairs group. The Manager level will lead a molecule or compound and work closely with the lead statistician and is responsible for programming analyses to support publications and presentations.
- Program complex adhoc analyses in a fast paced environment for medical affairs/publication purposes working outside of the standard programming function for R&D clinical trials
- Attend multi-disciplinary team meetings, representing the programming function.
- Develop software systems to generate displays of clinical study data as tables, listings, and graphs for Medical Affairs analysis requests.
- Assist statisticians by suggesting algorithms to address novel analysis requests
- Create and document archives of software, outputs, and analysis files.
- Create and maintain department SOPs related to statistical programming.
- Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.
- Possibly oversee work of internal contract programmers and external vendors.
- Provide time and resource estimates for project planning.
Required Knowledge, Skills, and Abilities
- Skilled in programming with SAS. Knowledge of additional programming languages a plus.
- Good knowledge of statistics methods such as GLM, Survival Analysis and the drug development process
- Experience as a lead programmer for a project and/or compound within the medical affairs environment.
- Ability to balance and prioritize multiple assignments and respond quickly to adhoc requests.
- Experience in performing analysis to support publications, conference presentations and internal decision making.
- Experience overseeing the work of internal contractors and possibly external vendors (CROs)
- Familiarity with CDISC standards, including SDTM and ADaM models
- Solid verbal and written communication skills
Required/Preferred Education and Licenses
- Bachelor's Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; Master's Degree preferred
- Minimum of 7 years of experience in developing software to analyze clinical data using the SAS system
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.