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Mgr Biostatistics

Date: Apr 7, 2021

Location: Bangalore, IN, 560052

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

  • Review of study protocol and provide inputs in the PK and statistical analysis sections of the study protocols for its correctness.
  • Preparation and verification of Standard Operating Procedures for Pharmacokinetic and Biostatistics.
  • Estimation of sample size justification.
  • Preparation/review of randomization schedules as per study design by using SAS software.
  • Estimation of PK parameters using Phoenix WinNonlin software.
  • Statistical analysis for the PK parameters by applying appropriate statistical methods using SAS software.
  • Preparation/review of statistical report.
  • Review of clinical study report and provide inputs in the PK and statistical analysis sections of the study report for its correctness.
  • Provide clarification of statistical queries from sponsor and regulatory authorities.
  • Maintaining the upgrade versions and qualification of SAS and Phoenix WinNonlin software.
  • Working knowledge of SAS programming and relevant Data Standards (such as CDISC ADaM) and TLFs.
  • Perform QC of derived datasets, tables, figures, and data listings produced.

Qualifications

MSC Stat/Biostat/PHD with 8+ years of experience.

Function

Research & Development

Sub Function

Biometrics

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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.