Regular Full-TimeJob Code
Questcor Pharmaceuticals, Inc. is a specialty biopharmaceutical company which provides products for patients with serious, difficult-to-treat autoimmune and inflammatory disorders. We support research in a number of rare conditions, including in treatment-resistant patient populations, in which there is significant need for improved therapeutic options. Questcor was awarded Orange County Register’s #1 Best Large Company of 2012 and Forbes’ Magazine’s #1 Best Small Company award in 2011, #7 in 2012, and #1 in 2013.
We are currently seeking a Biostatistician.Responsibilities:
- Responsible for developing, modifying and evaluating statistical elements of clinical and nonclinical research
- Collaborates with clinical scientists/program teams to design clinical (Phase 1-4) studies
- Provides statistical input into protocol and case report form (CRF) development for clinical studies (e.g., trial design, sample size estimation, randomization, statistical methods for protocols, edit checks for clinical trial data).
- Writes and/or reviews detailed statistical analysis plans for clinical studies including specifications for analysis files, definition of derived datasets, consistency checks, tables, listings and figures.
- Analyzes and/or reviews clinical study data producing accurate results representing the outcome of the trial; validates statistical output.
- Accurately interprets statistical results and concepts.
- Writes and/or reviews statistical methods sections for clinical study reports, and reviews and/or produces the statistical appendix for the final report.
- Collaborates with non-clinical scientists/program teams on experimental design, data analysis, interpretation and communication of data evidence for research & development, and/or marketed product needs.
- Provides statistical support for planning and execution of analyses for publications and presentations of study data; Co-authorship of publications and presentations is expected
- Develops and/or provides input into statistical standard operating procedures (SOPs) and general standardization efforts within the department (e.g., statistical methodology standards, standard data presentations) in accordance with GCP and ICH Guidelines.
- Participates in interactions with regulatory agencies, as required.
- Collaborates effectively with members of clinical and nonclinical study teams
To perform this job successfully, the individual must be able to perform each essential duty independently. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Understands and uses relevant computer languages and software packages. Able to work in the confines of our processes yet help to improve them as needed. Able to provide high quality work and achieve R&D goals.
Microsoft Word, Microsoft Excel, Graphpad Prism, SAS, Internet software, E-mail.
- Ph.D in Statistics, Biostatistics, or related field with applied statistics training relevant to clinical trials and/or health sciences research
- Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials
- Proficiency with SAS statistical software
- Minimum 3-5 years of pharmaceutical or related experience for statistical support of clinical development programs
- Experience collaborating with non-statisticians to design, analyze and interpret clinical studies
- Ability to appropriately apply statistical methodology
- Ability to exercise judgment and determine appropriate action.
- Ability to manage deadlines.
- Strong organizational skills.
- Ability to manage multiple projects in a fast paced environment
- Possess excellent communication skills (oral and written), including effectively being able to present information and respond to questions from project teams, external vendors, and KOLs
- Experience working with cross functional teams
Questcor Pharmaceuticals Inc. offers employees a Total Rewards package, which includes competitive base pay and bonus opportunities, excellent benefits, an outstanding work environment and the chance to grow, both financially and professionally.
For more information, you may view our website at http://www.questcor.com/careers/company-benefits.
Questcor is an Equal Opportunity Employer.