Biostatistics Group

US-NJ-Princeton
Requisition ID
2013-4480

Responsibilities

Provides statistical input in the clinical development plan and protocols and conducts statistical analyses to support Clinical Study Reports (CSR) and other regulatory documents (e.g., integrated efficacy and safety summaries, etc.) to help advance the drug development process and accurate labeling.

 

 

Additional Responsibilities Include:

 

40%

  • Takes full responsibility in managing all Biostatistical tasks for one core project.
  • Provides technical direction to supporting statisticians working on projects on a day-to-day basis.
  • Provides statistical input to clinical development plans (CDP).
  • Reviews protocol outlines and protocols.

30%

  • Provides statistical analysis plan including study design, sample size, primary and secondary endpoints and statistical analysis method.
  • Develops final tables and listings (and figures) for final study report (FSR)
  • Develops Table of Contents (TOC) and Tables & Listings templates
  • Develops a detailed Statistical Analysis Plan (SAP) to document technical considerations
  • Provides specs to SAS programmers for generating analysis datasets
  • Programs efficacy analysis and produce final efficacy tables and figures
  • Reviews final tables, listings, and figures.
  • Develops tables and listings (and figures) for other regulatory submission
  • Performs statistical analyses for PK/PD parameters
  • Provides safety tables and listings for IND annual reports and PSUR
  • Provides tables and listings for FDA meeting briefing packages
  • Performs exploratory analyses

    Performs statistical analyses for marketing and Phase IV studies

  • Performs statistical analyses for abstracts, posters and publications
  • Works on NDA submission
  • Provides Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety ISS) tables
  • Reviews ISS and ISE reports
  • Prepares briefing packages for FDA Advisory Meetings
  • Participates in responding to Advisory Committee questions in NDA defense.

30%

  • Produce Randomization codes
  • Review CRF
  • Review and approve database structure and edit-check specifications
  • Review and other clinical documents such as clinical operation manual, investigator brochure (I ), etc.
  • Develops of final study report (FSR)
  • Provides Statistical Methods section
  • Summarizes Efficacy Results
  • Reviews FSR
  • FDA contracts and regulatory meetings
  • Draft response to questions from regulatory agencies
  • Participate in preparing FDA briefing packages
  • Attend meetings with Regulatory Agencies

Qualifications

Education & Experience:

  • PhD degree in Statistics, Biostatistics, or Applied statistics
  • 3-12 years experience in pharmaceutical/bio-tech/CRO company or equivalent academic research experinece. (Experience level will dictate title)
  • 12 years in pharma drug development experience preferred


Knowledge:

  • Understands the company's products, the competition, and the pharmaceutical industry in general.
  • Demonstrates a competent knowledge of the company's work tools, processes, and policies.
  • Maintains a current awareness of new drug developments and statistical methodologies in the business.
  • Requires a strong working knowledge of applicable U.S. regulatory requirements and NDA preparation for submissions.
  • Advanced degree required
  • ~ 30% travel

Skills:

  • In-depth knowledge of statistical principles, applications, and SAS programming software.
  • Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word,Excel, PowerPoint, and Outlook).
  • Knows how/when to apply organizational policy or procedures to a variety of situations.

Overview

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016. 


All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

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