Novavax, Inc. a clinical-stage biopharmaceutical company is seeking an Associate Director, Biostatistics to join their team in Gaithersburg, MD.
Responsibilities include:
• Assists clinical team in designing all NOVAVAX-sponsored clinical trials and prepares all statistical sections of clinical protocols using appropriate statistical methodology for the specific trial, including selection of study design, sample size, and analyses.
• Reviews database design, CRF's, and edit checks.
• Prepares statistical analysis plans.
• Prepares statistical sections for relevant background documents for EU, Africa, and U.S. regulatory agencies
• Write SAS programs to create CDISC data sets, tables, figures, and listings
• Provides programming support to programming team when it is needed for the validation of clinical study tables and listings
• Provides effective guidance to Programmers. Good team player. Good business ethics. Good leadership skills.
• Manages effectively one's projects, and also meets deadlines while maintaining high quality standards
• Explains statistical designs and concepts to non-statisticians
• Other duties as requested to meet company milestones
Minimum Requirements:
• Master Degree in Statistics (or equivalent degree) with at least 8-10 years of relevant experience or PhD in Statistics with at least 4-6 years of relevant experience. Experience gained in the main tasks of a Senior Statistician (about 2-4 years).
• Knowledge of experimental design for clinical trials, power calculations, survival analysis and other methods for assessment of efficacy, and linear models.
• Familiarity with current ICH guidance pertinent to clinical development.
• Proven knowledge and expertise in biostatistics and its application to vaccine clinical trials. Solid knowledge and experience in vaccine development process, including evaluation of epidemiologic data for definition of key endpoints and assessment of correlates of risk.
• Able to thrive in a fast-paced team environment, and also work independently on projects.
• Very good communication and presentation skills. Ability to influence team members and communicate statistical concepts across functions.
• Thorough and up-to-date working knowledge of statistical software packages (e.g. SAS and R). Hands-on programming experience. Two to four years SAS programming experience (Base SAS, SAS/STAT, and SAS macro language) in a biotech or pharmaceutical company, or in a contract research organization servicing the pharmaceutical industry.
• Experience with CDISC is a must
If you are interested please visit their website at www.novavax.com.