American Veteran Magazine

 

Senior Manager/Associate Director, Biostatistics and Programming

Published
February 12, 2018
Category
Default  
Job Type

Description

At Novavax, a clinical-stage vaccine company, we are creating tomorrow's vaccines today! We seek to attract, develop, and retain talented people who share our passion for science, medicine, and human health. We foster an environment of teamwork and collaboration, built on a culture that values and appreciates its employees. We are a fast-paced company that provides employees with opportunities to achieve personal and professional goals while also maintaining a balance between work and personal life.

We are seeking a Senior Manager/Associate Director, Biostatistics and Programming to join our team in Gaithersburg, MD to gain invaluable experience working directly with the Head of Biostatistics and a team of Statistical programmers. This position will be filled at a level commensurate with experience.

 

Responsibilities include but not limited to the following:

  • 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 statistics sections for the clinical stud protocols and statistical analysis plans.
  • Prepares statistical sections for relevant background documents for EU, Africa, and U.S. regulatory agencies
  • Write specifications 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 including support for Clinical Immunology department

 

Minimum Requirements: 

  • Master Degree in Statistics (or equivalent degree) with at least 6-8 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 preferred

 

Novavax, Inc. is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Using innovative proprietary recombinant nanoparticle vaccine technology, we produce vaccine candidates to efficiently and effectively respond to both known and emerging disease threats. Our vaccine candidates are genetically engineered three-dimensional nanostructures that incorporate recombinant proteins critical to disease pathogenesis.

Our product pipeline targets a variety of infectious diseases, with clinical vaccine candidates for respiratory syncytial virus (RSV) and Ebola virus (EBOV), and preclinical programs for Zika virus (ZIKV), seasonal influenza and a combination respiratory vaccine candidate, as well as other infectious disease vaccine candidates.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax, Inc. offers a base salary, annual bonus, stock options, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity Employer/Veterans/Disabled

Novavax, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against

For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://www.applicantpro.com/j/728921-222192

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