This site uses cookies. To find out more, see our Cookies Policy

Biostatistician - Lenexa, KS req19564 in Lenexa, KS at Quest Diagnostics

Date Posted: 12/31/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Lenexa, KS
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    12/31/2018

Job Description

Schedule: 8:00 - 5:00 

Look for more than answers. Patients and Physicians rely on our diagnostic testing, information and services to help them make better healthcare decisions. These are often serious decisions with far reaching consequences, and require sensitivity, tact and a clear dedication to service. It’s about providing clarity and hope. 

You will work for the world leader in the industry, with a career where you can
expand your skills and knowledge. You’ll have a role where you can act with
professionalism, you can inspire colleagues, and you can care about the work we do and the people we serve. 

At Quest, we are on a continuous journey of discovery and development. It’s this attitude that has made us an industry leader and the #1 Diagnostic Lab in the US. For those joining us, we offer exciting and fast moving career opportunities where you can affect change at a rate unheard of in many organizations of our size and scope. While we invest in and develop technology to drive our innovations, our ongoing success relies on our people.

JOB SUMMARY

Responsible for establishing statistical methodology on product development, clinical trials, validations, and process improvements.  Responsible for supporting the organization in statistical methodology and analysis.  Responsible for ensuring the statistical validity of regulatory submissions and publications. Supports all applicable regulations and standards including but not limited to domestic, international, and ISO requirements.

JOB RESPONSIBILITIES

  • Works with company personnel to identify, isolate and correct technical challenges for improving product and process reproducibility.

  • Serves as statistical methodology expert for the organization.

  • Provides input as requested for changing procedures and updating processes

  • Improves understanding and utilization of statistical tools and methods throughout the organization.

  • Writes statistical sections of protocols (development, validation, clinical trials) and Marketing materials.

  • Interacts with regulatory authorities on statistical regulatory issues as required.

  • Creates experiment design plans.

  • Performs sample size calculations and provides justification of sample sizes.

  • Compiles statistical methods for studies including but not limited to, validations, clinical studies, and process data analysis.

  • Provide data analysis for research, process and product development, and manufacturing processes to determine the appropriate statistical method.

  • Communicates statistical issues and solutions with pre-clinical and clinical development team.

  • Assist in quality review of data to confirm it’s suitable for intended purpose or analysis.

  • Develops data collection systems to facilitate efficient data analysis.

  • Reviews clinical study data to confirm appropriateness.

  • Verifies methodologies used for data collection and analysis.

  • Monitor new methodologies and statistical techniques for the statistical analysis of clinical data.

  • Develops and presents training and training materials on statistics and related topics.

  • Assists with the evaluation, purchase, and implementation of statistical and Process Control System software and related tools.

  • Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees.  You also have a responsibility to cooperate in all safety or health-related programs and assist in solving safety and health problems.  Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process.

  • Perform other duties as assigned.

SUPERVISORY RESPONSIBILITIES

  • None.

JOB REQUIREMENTS:

 

Education:

  • Bachelor’s degree in Statistics, Biostatistics, Mathematics or Computer Science is required. (A Masters degree in Statistics or Biostatistics is preferred.)

Work Experience:

  • Must have at least 5 years of experience in IVD, medical, pharmaceutical, or other related industry. 

  • Proven ability to plan and implement statistical analyses independently and to use knowledge of clinical development and regulatory processes to advance projects.

  • Project management and communication skills consistent with supervising the work of others, consulting, and submission/publication preparation and review. 

  • Highly desirable to have working knowledge in biological and clinical sciences. 

  • Working knowledge of FDA, international regulations for design, conduct, and analysis of clinical trials.  Computational programming/simulation skills (preferred). 

  • Must have a thorough understanding of statistical quality control Statistical Process Control (SPC) and sampling strategies; Applied Multivariate Analysis; Control Theory; Time Series Analysis; Regression, ANOVA and Mixed Models; Design of Experiments (DOE); Nonlinear or Logistic Regression; Reliability Analysis; Categorical Data Analysis; Data Mining Techniques; and Six Sigma and their application as a problem identification and resolution tools.

Language Skills:               

  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. 

  • Ability to write reports, business correspondence, and procedure manuals. 

  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

  • Efficient and effective communication skills, to impart information about complex statistical issues to wide audience with little to large amounts of statistical knowledge.

  • Requires the ability of use data to compose reports, documents and presentations. 

  • Ability to edit and proof data with detailed accuracy.

Mathematical Skills:

  • Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. 

  • Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.

  • Familiarity with principles of clinical study design as well as analytical methods used in product development will be required as well as strong statistical skills and the ability to review the statistical and scientific literature to identify appropriate methodology.

Reasoning Abilities:

  • Ability to define problems, collect data, establish facts, and draw valid conclusions. 

  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. 

  • Ability to communicate complex statistical solutions to a wide array of colleagues at various levels of statistical understanding.

  • Ability to manage several projects simultaneously.

  • Ability to prioritize and manage priorities.

  • Ability to change direction, priorities to meet fluid company objectives. 

  • Possess the ability to deal with problems involving several variables in non-standardized situations.

  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. 

  • Receives no instructions on routine work, general instructions on new assignments. 

  • Attention to detail. 

  • Must demonstrate the ability to get results despite a large workload, competing demands in a fast paced environment. 

  • Must have the ability to understand regulatory requirements and technical standards.

Certificates, Licenses, Registrations:

  • ASQ Certification desired, but not required.

Physcial Demands:

  • While performing the duties of this job, the employee is occasionally required to stand, walk, sit, use hand to finger, handle, feel, reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, talk and hear. 

  • The employee must occasionally lift and/or move up to 25 pounds. 

  • Specific vision requirements involve close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

Work Environment:

  • The noise level in the work environment is usually moderate.

OSHA RISK CATEGORY

  • Category II – may encounter potential exposure.