• United States Of America, Usa
  • Save Job
  • 4 - 7 Years
  • Posted : above 1 month

Job Description:

Those who join AstraZeneca feel a sense of ownership about their future They thrive with a recognized leader in the industry AstraZeneca is an agile, fast-moving and emerging industry leader in oncology We are a nimble organization that values smart risk-takers

With AstraZeneca, you will be applying a creative approach to science while being at the forefront of a strong and rich pipeline of cutting-edge medicines Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives You will excel in an environment characterized by respect, integrity and growth opportunities

Our Oncology Pipeline

Our robust pipeline includes investigational therapies in varied stages of clinical development, from recently approved products to earlier-stage molecules in clinical trials We aspire to transform the lives of cancer patients, working to eliminate cancer as a cause of death in the future

We have an exciting opportunity for a Principal Statistician or Statistical Science Director depending on your level of experience located in our Gaithersburg Maryland Office

Position Summary

Please note this this position can be filled at either the Principal Statistician level or the Statistical Science Director level With the Statistical Science Director having significant experience in Industry and PhD Preferred

In this role you will provide statistical expertise for complex design and interpretation of clinical studies, regulatory submissions and commercialization You will also act as a coach/guide for less experienced statisticians in the production of analysis, supporting graphics and analysis tables for CSRs, GMA studies or publications

You will also

Analyze internal and external information to inform design decisions and the development of decision criteria
Develop a Statistical Analysis plan for complex studies and/or project deliveries
Provide support to the complex study analysis, regulatory submissions including specification of overview documents and response to regulatory questions
Contribute to the regulatory submissions including specification of overview documents and response to regulatory questions
Identify opportunities for the application of modelling and simulation to improve study design
Identify and apply statistical methodology to improve the process and delivery activities
Perform ad hoc and exploratory data analyses
Contribute to the development of best practice to improve quality, efficiency and effectiveness

Requirements

MSc or PhD in Statistics, Biostatistics, or Mathematics (containing a substantial statistical component)
Preferred 4 years experienceworking within a statistical role for Principal Level More years experience will be required for a Statistical Science Director level, both however preferably in pharma/healthcare or other relevant area
Knowledge of the technical and regulatory requirements related to the role and able to guide others on these
Experience in drug development, study design, and data analysis and interpretation
Excellent communication skills and ability to build strong relationships
Excellent collaboration skills required the energy to work across global & functional boundaries, both internally and externally
Project management skills
Ability to apply statistical expertise to complex problems, problem solving and quality focus

Desirable Qualifications

Experience in Oncology product development
Coaching skills
Experience in commercial or early development support work
Expert statistical programming skills (SAS and R)

Level (Statistical Science Director vs Principal) to be commensurate with experience and abilities

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Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Teaching/Education
Role : Teacher
Salary : As per Industry Standards
Deadline : 09th Mar 2020

Key Skills:

Company Profile:

Company
ASTRAZENECA PHARMA INDIA LTDarfix

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