Teva Pharmaceuticals USA, Inc.

Associate Director Statistics

US-PA-Great Valley
Requisition #
17-20331
# Positions
1
Category
Biostatistics

Overview

 Position Summary

The Associate Director, Statistics position is for a skilled statistician with training and significant experience in drug development and clinical research.  He or she is expected to provide statistical leadership for overall program and individual study strategy within a therapeutic area. He or she needs to be knowledgeable about statistical principles and appropriate software and tools to perform his or her tasks.   An Associate Director, Statistics must be a strong individual contributor, demonstrating leadership qualities, creative and strategic thinking and knowledge of cutting-edge clinical trial design and methodology for phase 2 and 3 studies. He or she must experience with regulatory submissions both in the US and outside of the US. He or she must have excellent written and oral communication skills. This position will be located in Malvern, PA or Netanya, IL.

 

 

 

 

 

 

Responsibilities

Essential Functions:

 

Responsibilities

  • Responsible for statistical aspects of the design, implementation, and analysis of clinical studies to support global regulatory submissions. Works with multi-functional areas of the organization to determine necessity and type of research required.  Works with statistical programmers, clinical research, and other statisticians to plan, analyze, and report clinical study data. Communicates results to relevant audiences.
  • Provides strategic study design input and consultation for clinical research protocols and clinical development plans
  • Leading clinical development and global statistics through the use of novel/innovative clinical trial designs and statistical methodology
  • Becomes proficient in the knowledge of the therapeutic area and competitive landscape of the specified therapeutic area
  • Provides consultation on clinical endpoint assessments and sample size planning for clinical studies
  • Prepares, or oversees the preparation of, statistical sections of clinical protocols in collaboration with Clinical Research personnel.
  • Writes, or oversees the writing of, statistical analysis plans
  • Works with Data Management and Clinical Research personnel to provide statistical input for CRF design
  • Conducts, or oversees the conduct of, analyses to support clinical study reports, abstracts, manuscripts and other documents to support the marketing of Teva products
  • Ensures that data sets and their associated define files are prepared correctly and on time to support FDA submissions
  • Leads efforts to select CROs for outsourcing of statistical activities when required
  • Collaborates with outsourcing partners and oversees conduct of statistical aspects of outsourced studies, as appropriate
  • Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives
  • Consults, mentors, and teaches other Statisticians on statistical methodology, trial design, and data analysis strategies
  • Help develop and maintain departmental SOPs and ensure their compliance in daily work
  • Supports due diligence activities

Qualifications

 

  • Requirements

    Ph.D. in Statistics/Biostatistics (or related field) with a minimum of 7 years of related experience

    • Excellent presentation and written communications skills.
    • Ability to communicate with non-statisticians to interpret statistical findings
    • Experience working in an outsourcing model (fully or functional outsourcing)
    • Good organizational and problem-solving skills.
    • Demonstrated project and technical leadership qualities, and creative and strategic thinking required.
    • Ability to program using SAS, knowledge of R is beneficial
    • Knowledge of CDISC SDTM and ADaM
    • Knowledge of relevant FDA and CHMP guidelines
    • Experience with regulatory submissions in the US
    • Experience with regulatory submissions outside the US
    • Demonstrated ability to deliver quality products with efficiency as well as having relevant technical and scientific publications is preferred.

 

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