Principle Biostatistics
  • Gaithersburg, Maryland, US
  • +914043515100
4 Days ago
Job Description
Gaithersburg, MD
Contract Duration: 12-36 months
Rate: Negotiable
Salary: NA $1.00

Responsibilities:

 

  • Excellent employment opportunity for an Principle Biostatistics in the Gaithersburg, MD area.
  • Provides technical knowledge as an expert for a number of statistical processes and systems through a regional based group that ensures effective collaboration between a technical services group and the Company regional sites and customers. 
  • Develop and build, or act as a specialist expert within, a cross-functional multi-skilled team comprised of experts across multi-disciplinary project teams.
  • Biostatistics Contractor is a delivery focused role working under the leadership, oversight and direction of assigned Company Supervisor, responsible for activities relating to design, delivery and interpretation, preclinical studies, regulatory submissions and/or commercialization. 
  • The position requires sufficient experience working as a Statistician in the Pharmaceutical industry, to be able to independently perform and/or lead statistical work within a study multiple studies, indication, or be recognized as a methodology expert. 
  • Able to support and/or lead work either in house or partnering externally to ensure delivery to standards, quality and time.
  • May serve as a supporting or lead statistician for a study, multiple studies, indication within a project (potentially as a Global Product Statistician) or a project-level activity.
  • such as a regulatory or payer submission, responsible for statistical elements of the design, analysis, interpretation and/or reporting.
  • Quantifies the benefit, risk, value and uncertainty of the emerging asset/product profile.
  • Develops design options and provides high quality deliverables to support the business in making informed decisions.
  • Contributes to statistical methodology advances by identifying new opportunities, investigating and applying novel statistical approaches, including modelling and simulation.
  • Ensures high quality is built into own and other statisticians’ deliverables
  • Ensures compliance with standards and external regulations
  • Contributes to the development of best practices to improve quality, efficiency and effectiveness within function
  • Plans and supports Team’s project activities and tasks
  • Communicates and escalates risks within the assigned studies and/or projects
  • Collaborates internally and externally, to ensure delivery to standards, quality and time

 

Experience:

 

  • MSc/PhD in Statistics or Mathematics (containing a substantial statistical component) with experience in pharma industry
  • Very good SAS and R programming skills
  • Thorough knowledge of the technical and regulatory requirements related to the role
  • Experience in the study and/or program design, development, data analysis and interpretation, as well as regulatory interactions and/or submissions
  • Ability to proactively manage concurrent activities within a study or project
  • Ability to apply novel statistical methods to problem solving
  • Ability to manage relevant documentation
  • Excellent communication skills and ability to build strong internal and external relationships
  • Clinical statistician with Project experience (Principal Statistician or a GPS - Global Product Statistician)
  • Previous Therapy Area experience
     
Industry
  • Pharmaceutical

Required Skills
  • SAS,Statistics,DATA ANALYSIS,pharmaceutical,Mathematics,regulatory,technical,therapy area,R programming

Experience
  • 2-3 Years of Experience

Salary
  • NA

Working Hours / Week
    NA