Biostatistician

Responsible for providing statistical and programming support to Medical Affairs projects. Will participate in the development of study protocols including participation in study design discussions and running scenarios and modeling to determine the best strategy for any Phase IV study. Reviews CRFs and data edits.

Develops statistical analysis plans including analysis files and report/programming specifications. Performs statistical analyses including the production of tables, listings and figures, interpreting statistical results, and helps prepare study reports for presentations and publications. Responsible for managing project related analysis and programming execution.

Detailed Responsibilities:
• Protocol Design. Participates in protocol development ensuring that the design meets the objectives and is optimal within the imposed constraints. Performs sample size estimates and/or power calculations to evaluate the costs of various design scenarios. Reviews CRFs and data edits. Proposes methods for statistical analysis and prepares statistical section of protocols.
• Analysis. Prepares statistical analysis plans (including specifications for analysis files and report tables), and performs the analyses of the clinical data.
• Computing. Understands and utilizes those aspects of computer science necessary for efficient data management and statistical analysis. Conducts complex statistical analysis utilizing SAS and other statistical software packages, as required. Creates, maintains, updates, and documents SAS programs for statistical analysis.
• Presentation of results. Interprets statistical results and presents findings in an appropriate format. Helps prepare the statistical methods and results sections of clinical study reports ensuring that graphical and tabular summaries are clear and concise and that the objectives of the study are addressed. Presents statistical results to non-statisticians for clinical interpretation. Also assists with development of statistical sections of manuscripts and presentations.
• Maintenance of records. Maintains project files ensuring adequate, clear documentation of data sources, management and analysis.
• Consultation. Provides general consultation and training to appropriate Company personnel, usually on an informal, as-needed basis.
• Professional Development. Maintains proficiency in statistics through training courses, participation in appropriate societies, review of professional literature, industry and academic contacts, etc.

Qualifications:
• MS with 3 years or PhD with some experience working on clinical trials in the pharmaceutical industry and/or biotechnology industry.
• Thorough understanding of statistical principles with the ability to practice and implement them. Ability to provide solutions to a variety of technical problems of moderate scope and complexity.
• Proficiency and experience in SAS programming, and knowledge of SAS procedures and other statistical software.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Effective communicator: able to explain methodology and consequences of decisions in lay terms.
• Effective team player: willingness to go the extra distance to get results, meet deadlines, etc.
• Able to be flexible when priorities change. Able to deal with ambiguity.
• Some knowledge of medical/biological terminology and clinical practice in relevant therapeutic areas is preferred.
• Working knowledge in FDA guidelines relating to statistical analysis, study reports and statistical components of new drug applications is preferred.

About Biogen Idec: Transforming Discovery into Care
With operations across the Americas, Europe, and Asia, Biogen Idec (NASDAQ:BIIB) is one of the world's leading biotechnology companies, creating new standards of care in oncology, neurology, and immunology. Every day, employees of Biogen Idec make a difference in people's lives, through pioneering research and development, manufacturing, and our worldwide commercial capabilities.

Learn more at www.biogenidec.com/careers.

Biogen Idec is proud to be an equal opportunity employer.

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