Biostatistician Sr.

Our Strength Is Our People. Passion. Principles. Perspective. At Watson, they're the traits that drive our growth and we apply them to every project and product. If you bring these qualities to your work, then we'd like you to consider joining our team.Under general direction, provides statistical support in the design and analysis of clinical trials. Reviews statistical aspects of clinical study protocols and reports, and prepares the relevant sections for inclusion in both document types. Develops and executes statistical analysis plans, interprets the results, and generates tables, listings, and figures. Review and approve statistical contributions to Phase I / II Studies. Essential functions include:
Participates in the development of clinical trial designs including the selection of
appropriate statistical methods and tests, sample size calculations and creation of
randomization schedules.
Prepares statistical method sections for inclusion in study protocols. Reviews and signs
protocols for Phase I / II studies.
Reviews the design and content of Case Report Forms, database designs, and data edit checks. Reviews and approves Case Report Forms for Phase I / II studies.
Develops and validates SAS programs to support statistical analyses.
Develops and executes statistical analysis plans including generation of tables, listings, and figures. Reviews and approves statistical analysis plans for Phase I / II studies.
Provides interpretations of statistical results, and prepares the relevant statistical sections for clinical study reports. Reviews and signs Clinical Study Reports for Phase I / II studies.
Creates and maintains biostatistical documentation, including descriptions of methods,
SAS programs and results.
Prepares electronic files using appropriate formats for submission to regulatory agencies.
Participates in the development of standardization procedures for statistical functions.
Presents new statistical methods at the statistical group meetings.
Reviews and audits statistical analysis plans, SAS programs, and statistical reports including tables, listings, and figures.
Provides guidance to more junior biostatisticians.
Evaluates and proposes new statistical methods for data analysis.
Performs related duties as assigned.Qualifications
Bachelors degree in statistics or biostatistics from an accredited college or university, Three(3) to five (5) years experience supporting clinical trial research, or an equivalent combination of education and experience. Fluent working knowledge of SAS. Knowledge of:Application of statistical principles and methods in clinical trial research.
General principles and experimental methods in clinical research.
Statistical programming including extensive knowledge of SAS.
Database structures and data handling procedures.
Business, and scientific software applications.
Business English usage, spelling, grammar and punctuation.
Relevant FDA regulations/guidelines and ICH guidelines.Watson offers competitive medical and dental benefits, including vision, 401(k) and educational reimbursement.Watson Pharmaceuticals, Inc. is an Equal Opportunity Employer M/F/D/V. We value the benefits of diversity.Apply Online Now!
REQUIREMENTS
Please see Job Description