1 Director, Biostatistics Job in Sacramento, CA
Jazz Pharmaceuticals is Hiring a Director, Biostatistics Near Sacramento, CA
Essential Functions
- Lead early phase oncology drug development projects by developing and executing statistical strategy, design, and analyses for clinical trials.
- Manage biostatisticians within the drug development projects.
- Manage CROs providing statistical support to ensure timely delivery of quality analysis results; oversee contracts and invoices.
- Approve guidelines and standards of CROs to ensure quality of deliverables.
- Contribute to or lead Biometrics teams to develop, implement, and maintain department standards and practices.
- Provide technical support and input to project statisticians and statistical tasks.
- Provide statistical expertise to prepare for meetings with regulatory agencies; attend meetings with regulatory agencies; respond to statistical questions from regulatory agencies and support and defend clinical programs.
- Collaborate with researchers and thought leaders in the planning of clinical development programs and the publication of study data.
- Present study results to internal and external audiences.
- Develop statistical programs as necessary to simulate clinical trial design operating characteristics, simulate clinical trial design operating characteristics, perform analysis, prepare data displays, and verify the correctness of data and analyses.
- Be able to conduct independent research and resolve statistical methodological issues.
- Recruit, develop, and supervise internal and external statisticians to achieve project goals.
- May lead outsourcing statistical activities within a program.
- Expert knowledge of clinical trial design and analysis, including experience with complex statistical methods and models.
- Experience in using SAS or R; knowledge of other statistical applications and programming languages a plus.
- Expert knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines and drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC SDTM and ADaM standards.
- Able to work in a fast-paced, flexible, team-oriented environment.
- Possess excellent interpersonal and communication skills (written and verbal).
- Strong attention to detail with a view to bring studies to a quality conclusion.
- Flexible, positive, creative thinker, good communicator.
- Work without close supervision. Well-developed time management skills are important.
- PhD or MS degree in statistics, mathematics, or a related discipline with a statistical focus.
- A minimum of 8 years of experience; supervisory experience is preferred.
- Expert knowledge of statistical designs of early phase oncology studies
- Expert knowledge of drug development regulations pertinent to statistical analysis.
- Bayesian Phase I and Phase II oncology study design experience.
- Knowledge of clinical pharmacology and translational science preferred.
- Experience in contributing to IND submissions and defense is required.
- Experience with NDA or BLA submissions preferred.
- Proficient SAS programming skills, solid understanding of CDISC models and standards.
- Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills.
- Occasional mobility within office environment.
- Routinely sitting for extended periods.
- Constantly operating a computer, printer, telephone, and other similar office machinery.
- Works indoors in normal office environment with little exposure to excessive noise, dust, fumes, and temperature changes.
- Computer use at a 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.
Job Summary
Contractor
Pharmaceutical
$189k-240k (estimate)
07/04/2024
07/26/2024
jazzpharma.com
PALO ALTO, CA
500 - 1,000
2003
Private
BRUCE C COZADD
$1B - $3B
Pharmaceutical
Related Companies
The job skills required for Director, Biostatistics include Biostatistics, Analysis, Leadership, Clinical Trial, Programming, Drug Development, etc. Having related job skills and expertise will give you an advantage when applying to be a Director, Biostatistics. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Director, Biostatistics. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Director, Biostatistics positions, which can be used as a reference in future career path planning. As a Director, Biostatistics, it can be promoted into senior positions as a Top Clinical Information Systems Executive that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Director, Biostatistics. You can explore the career advancement for a Director, Biostatistics below and select your interested title to get hiring information.
Similar Jobs
Popular Articles
