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Senior Biostatistician-Davie FL.

Date: Apr 24, 2019

Location: Davie, Florida, US, 33314

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

Under general direction, provides technical assistance and expertise in statistical data analysis for Annual Product Review (APR), product and laboratory investigations, process validation, equipment/facility/utility and computer qualification.  Assist the Quality Assurance and Operations management in implementation of quality improvement and efficiency projects.

 

  • Carries out responsibilities in accordance with the organization’s policies and procedures, state, federal and local laws.
  • Assists the Quality Engineering group in laboratory investigation of aberrant and out-of-specification results.
  • Provides technical assistance through application of statistical methods for determination of specifications, sampling and testing methodologies and inspection sampling.
  • Assists with trouble shooting and problem solving activities related to process, laboratory and manufacturing activities.
  • Assists in the evaluation of key quality trends.
  • Assists in the institution, monitoring and review of key quality indicators.
  • Assists in the evaluation of data resulting from annual product review as necessary.
  • Provides support on advanced features of the statistical software.
  • Provides training in basic and advanced statistics as needed.
  • Prepares statistical report for Annual Product Reviews (APRs).
  • Update Product Scorecard for release data.
  • Prepare statistical assessment for process validation.
  • Responsible for reducing/removing intermediate testing and optimizing specification limits project.
  • Responsible for providing corrective action preventive action (CAPA) support.
  • Responsible for revising and implementing department procedures.
  • Responsible for performing additional related duties as assigned.

Qualifications

Education/Certification/Experience:

  • Requires a Bachelor’s Degree in Mathematics, statistics or related field from an accredited University or college.
  • Minimum of 5 years relevant progressive experience in the pharmaceutical industry.

Skills/Knowledge/Abilities:

  • Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
  • Pertinent federal, state and local laws and regulations.
  • Ensuring compliance with company policies, practices and procedure, including safety rules and regulation.
  • Personal computer hardware and software applications including statistical software.
  • Principles of mathematical computations and statistical analysis; probability, descriptive statistics, applied statistics, central tendency, distributions, advanced regression analysis (single and multiple), hypothesis testing, and analysis of variance.
  • Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures and/or techniques for resolution.
  • Analytical laboratory methodology used to assess quantitative pharmaceutical product parameters.
  • Quality engineering problem solving techniques and investigation tolls including but not limited to statistical process control (SPC), acceptance sampling, process capability and design of experiments (DOE).
  • Communicating clearly and concisely, both orally and in writing.
  • Establishing and maintaining cooperative working relationships with others.
  • Managing multiple projects, duties and assignments
  • Attention to detail

Function

Research & Development

Sub Function

Biometrics

Reports To

In process of validation

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


Nearest Major Market: Fort Lauderdale
Nearest Secondary Market: Miami

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