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Associate Director, Statistics / Location: Frazer PA

Date: Nov 30, 2018

Location: Frazer, Pennsylvania, US, 19355

Company: Teva Pharmaceutical Industries Ltd.

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

Overview

Location: Frazer, PA or NETANYA ISRAEL

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 clinical 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.

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

•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 CNS 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

Note: this position can be located in either Frazer, PA or NETANYA ISRAEL

Qualifications

Requirements

MA/MSc/PhD 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.

https://careers.teva/job/Frazer-Associate-Director%2C-Statistics-Location-Frazer-PA-Penn-19355/522263300/?locale=en_US

Note: this position can be located in either Frazer, PA or NETANYA ISRAEL

 

Function

Research & Development

Sub Function

Clinical Development

Reports To

Director, Statistical Head of Clinical Pharmacology

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, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


Nearest Major Market: Philadelphia

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