Senior Manager, Biostatistics
Category: Research & Development| Country: United States | State: Pennsylvania| City: Philadelphia | Type: Regular, Full Time | Job ID: 4653
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 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 Senior Manager, Biostatistics will be functioning as a statistical lead on Jazz Pharmaceuticals clinical development projects. This position will work collaboratively with clinicians, data managers, biostatisticians, and statistical programmers in the planning, conduct, and analysis of clinical studies in all phases.
- Provide timely and scientifically sound statistical expertise to clinical development projects and develop/execute statistical strategy, design, and analyses for clinical trials
- Work with biostatistics compound/therapeutic area lead, peer management, and employees to develop, implement, and maintain department standards and practices
- Develop/write statistical analysis plans and provide data interpretation.
- Develop statistical programs as necessary to perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming
- Collaborate with members of project teams to establish project timelines and to develop and implement protocols
- Help design data capture methods and select appropriate study endpoints for clinical programs
- Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results
- Provide guidelines and standards to CROs to ensure quality of deliverables
- Respond to statistical questions from regulatory agencies
- PhD or Master’s Degree in Statistics, Mathematics, or related fields
- A minimum of 5 years of experience in pharmaceutical or biotechnology industry is required
- Strong knowledge of clinical trial design, sound understanding of statistical applications for clinical trials
- Good knowledge of drug development regulations pertinent to statistical analysis
- Experience in contributing to NDAs/BLAs submission
- Proficient SAS programming skills, solid understanding of CDISC models and standards
- Excellent writing and communication skills, and demonstrated interpersonal skills
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.