Peregrine Pharmaceuticals, on the list of Deloitte & Touche’s 500 fastest growing North American technology companies, invites you to bring us your excellent hands-on biostatistician expertise and proven abilities in the pharmaceutical industry. Peregrine has launched a Phase III lung cancer clinical trial for our lead drug therapy Bavituximab, which has been given a fast-track designation by the FDA.
If you meet the following criteria we encourage you to apply to become part of our successful team:
The Biostatistician will participate in the planning and execution of statistical tasks for assigned Peregrine Clinical Trials including advising on clinical program strategy and statistical design of clinical trials, the preparation and maintenance of analysis plans, performing statistical analysis and ensuring quality-controlled production of tables, listings and graphs. The position may serve on departmental teams.
Other activities, special projects and assignments may be given as required.
ESSENTIAL DUTIES AND RESPONSIBILITIES
•Writes analysis plans and statistical reports and reviews joint clinical/statistical reports.
•Develops statistical tables and data listings.
•Generates tables, listings and figures for presentations, posters and manuscripts.
•Reports statistical results summarizing the results of multiple trials for regulatory submissions.
•Plans methods to collect information and reviews or assists in development of case report forms and databases according to study design.
•Evaluates reliability of source information, adjusts and weighs raw data, and organizes results into form compatible with analysis by computers or other methods.
•Instructs clinical research staff on applicable statistical principles.
•Interaction and/or management of CRO statisticians or statistical consultants.
•Requires a Master’s degree in statistics/biostatistics with a minimum of 3 years of oncology clinical trials experience. A Ph.D. in statistics/biostatistics is a plus.
•Prefer pharmaceutical or biotechnology industry experience.
•Must have sound knowledge of theoretical and applied biostatistics.
•Need a solid understanding of regulatory guidelines in a pharmaceutical research setting.
•Good verbal and written communication skills.
•Demonstrated ability to read, analyze, and interpret scientific and technical journals, statistical texts, government regulations, financial statements, and legal documents.
•Ability to respond to inquiries or complaints from customers, regulatory agencies, or members of the medical community.
•Proficiency in writing articles for publication, presentations, operating procedures, procedure manuals, and business correspondence.
•Proficiency with explaining statistical concepts and results of data analyses to non-statistical audiences and project team members.
•Good organizational and problem-solving skills.
•Demonstrated ability to comprehend and apply principles of advanced calculus, modern algebra, probability and advanced statistical theory.
•Ability to work with concepts such as probability distributions, limits, rings, quadratic and differential equations, and proofs of theorems.
•Requires mastery of at least one statistical programming language (e.g., SAS, S-Plus).
•Proficient with Microsoft Word, Excel and PowerPoint.
•Knowledgeable with the concepts of database structure. Ability to work with data processing, programming, systems design, problem, analysis, and hardware.
Occasional overnight travel by land and/or air may be required to attend meetings, out of state site visits, conferences, etc.
Please note this position is based in Orange County, CA and is a full time onsite role. Competitive relocation assistance within the continental USA will be provided for well-qualified individuals.
EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER
Peregrine Pharmaceuticals strongly supports and values the uniqueness of all individuals and promotes a work environment where diversity is embraced.
Biostatistician, biostatistics, statistical, stats, analyze, quantitative, analysis, data, research, statistical modeling, data analysis, SAS, SQL, cancer, CA, California, Irvine, Tustin.