Staff Biostatistician

Location: Elmsford, NY
Job Type: Direct Hire
Salary: $1.00 - $1.00
Degree: Master of Science;
Date: 11/1/2017
Job ID: 02533171
Job Description
Staff Biostatistician
(Or Senior Staff - Depending on Level of Experience)
East Coast (NY, NJ, or DE)
Competitive Salary, Bonus, 6% 401K, 4 Weeks PTO, Excellent Benefits
 
We have a newly created opening for an experienced Senior (Staff or Senior Staff Level) Biostatistician with a longstanding client; a multi-billion global medical diagnostics/instrumentation company. They have strong revenue growth, a stable environment, very low turnover, and offer the opportunity to work on customized, complex medical products that impact people's lives. This is an ideal role for candidates who are detail-oriented, have strong problem solving and scientific thinking skills, a collaborative mindset, and enthusiasm for topics related to data analysis, programming, presentation of data, and science. A willingness to share this enthusiasm with colleagues and to have fun is a must. The  Biostatistician will provide technical leadership within the Statistical Affairs Department in conduct and analysis of studies directed towards the development, verification, validation, and monitoring of medical products. This role works across Clinical Affairs, Design Quality Engineering, Design Quality Systems, and Global Development to ensure a high quality of data & analysis results in regulatory submissions.
 
Key Responsibilities
  • Responsible for designing, planning, and executing statistical analyses of studies directed towards the development, verification, validation, and monitoring of products
  • Develops and uses statistical methodology to evaluate analytical and clinical study data.
  • Interprets and evaluates test data and results of very complex studies and develops appropriate recommendations.
  • Perform detailed review of clinical study protocols and development plans to ensure that the appropriate data collection and statistical analysis requirements are specified to support study endpoints.
  • Develops the statistical component of protocols for development-phase projects
  • Ensure that clinical monitoring plans, data management plans, and statistical analysis plans are harmonized and ensure delivery of high quality data and analysis results for regulatory submissions
  • Interact with members of the Data Management and Clinical Affairs teams to align scientific aspects of the clinical study to data collection, monitoring, and analysis activities.
  • Develops Statistical Analysis Plans (SAP) for clinical studies, maintains plan through life cycle of study, and executes analyses per plan.
  • Develops statistical analysis programs to merge complex data structures from multiple databases, create analysis data set (ADS) and generate tables, listings, and figures (TLF) for reports. Provides complex specifications and directions to clinical data analysts for creation of ADS and/or TLFs.
  • Participate in development of database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations. Ensures data specifications align with statistical analysis requirements and goals.
  • Contributes to the development of processes, procedures, and standards associated with analysis of clinical studies, data management, and reporting for regulatory submissions.
  • Mentors statistical staff on statistical methodology and programming. Assists in departmental training of staff.
  • Keeps abreast of new developments in statistics, industry development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
 
  • PhD/Masters degree in Statistics/Biostatistics strongly preferred
  • 8-25+ years experience, with expertise in statistical and data analysis with medical diagnostics, medical devices, pharmaceutical, life sciences, or similar. Must have some experience with R&D based, clinical trials.
  • Proficiency in statistical programming (SAS, R) and query of relational database systems (SQL). Certifications in SAS programming a plus.
  • Experience with extraction of data and reporting within Clinical Data Management systems (e.g. Medidata RAVE, Medrio, Oracle Clinical).
  • Strong knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, sample size calculations.
  • Desired knowledge of statistical methodologies such as Quality by Design, Design Space, Experimental Designs, Regression.
  • Ability to work independently and in project teams - mentor & lead junior Statisticians
  • Ability to understand scientific questions and formulate statistical and data-analytic methods to provide solution to novel problems.
  • Experience with analysis of complex data from multiple source.
  • Excellent communication skills (written and spoken). Strong ability to interact with others and to distill complex concepts in simpler terms to generalized audiences