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Education and Experience
Education or education/experience combination equivalent to a post graduate degree in statistics or statistics-related field. At least two (2) years of pharmaceutical experience with a Ph.D. or Ph.D. equivalent. At least four (4) years of pharmaceutical experience with a master's degree or master's degree equivalent.
Knowledge of FDA’s QSR 21 CFR Part 820 and 21 CFR Part 11, ISO 9001: 1994, EN 46001;1996, ISO 13485:1996, Council Directive 93/42/EEC June, 1993 (Medical Devices Directive) and the Canadian Medical Device Regulations: 1998.
Knowledge of FDA regulations with regard to medical device clinical trials, preferably Class III Devices; GCP’s and medical device manufacturing or a related field.
Knowledge of systems design and large clinical trials/biologics.
Skill in assessing performance.
Ability to demonstrate statistical expertise with regard to clinical studies in at least one topic for each of design, analysis, and methodology:
o Design – cross-over, multiplicity, interim analyses, non-inferiority, sample size and/or power
o Analysis - treatment by center interaction, multi-center, missing value imputation, covariate, and/or subpopulations
o Methodology - analysis of variance and mixed linear models, survival analysis, categorical data analysis, reliability, multivariate analysis, robust estimation, nonparametric techniques, and/or group sequential analyses.
Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts.
Ability to lead and motivate others.
Ability to meet deadlines; take initiative and make decisions within department/company guidelines.
Ability to perform detail oriented work.
Ability to plan extensively, usually affecting numerous employees and activities and requiring a significant amount of time.
Ability to coordinate and synchronize multiple projects and be flexible in changing daily workload priorities.
Ability to travel on business as necessary including overnight stays.
Ability to maintain accuracy, consistency, and quality in a fast-paced, multi-task environment.
Ability to guide and delegate to subordinates and analyze training needs and conduct training.
Ability to demonstrate leadership in job performance by example.
Ability to function in a controlled environment regulated by FDA QSRs and to handle confidential data.
Ability to use statistical computer software, particularly SAS®.
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