Senior Manager, Statistical Programming
Category: Research & Development| Country: United States State | State: California | City: Palo Alto | Type: Regular, Full Time | Job ID: 4322
Same Job Available in Two Locations
Palo Alto, California, United States
Philadelphia, Pennsylvania, 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 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 Senior Manager, Statistical Programming will
- Lead/support all statistical programming activities for a Hematology Oncology compound.
- Manage/support stat programmers working on this compound across sites
- Ensure stat programming deliverable timelines are met with quality, making sure regulatory guidelines are met.
- Partner with Biostatisticians and other functional group leads to move projects forward
- Participate and/or lead technical initiatives within the Biostatistics group
- Responsible for all statistical programming activities within an oncology therapeutic compound
- Lead, manage, develop and support statistical programming team
- Manage critical deadlines, demonstrate ability to problem solving, and ensure quality statistical programming deliverables will be completed within designated timeframe.
- Serve as project leader on studies or tasks of greater complexity
- Attend multi-disciplinary team meetings, representing the statistical programming function.
- Create or review and approve programming plans at study and project level.
- Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.)
- Provide programming leadership for preparation of datasets and TLGs (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies
- Develop software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies
- Assist statisticians by suggesting algorithms to address novel analysis requests
- Develop software validation procedures and test plans, as necessary.
- Create and document archives of software, outputs, and analysis files.
Required Knowledge, Skills, and Abilities
- Skilled in programming with SAS. Knowledge of additional programming languages a plus.
- Good knowledge of statistics and drug development process
- Experience as a lead programmer for NDAs/BLAs
- Experience overseeing the work of external contractors and external vendors (CROs)
- Experience in pharmacokinetics/pharmacodynamics modeling a plus
- Good knowledge with CDISC standards, including SDTM and ADaM models
- Solid verbal and written communication skills
Preferred Education and Licenses
- Bachelor’s Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; Master’s Degree preferred
- 10 years of experience in developing software for clinical trials using the SAS system, experience supervising SAS programmers is a plus.
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.