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Statistical Programming Associate Director

Ort Bengaluru, State of Karnataka, Indien Anzeigen-ID R-202813 Veröffentlichungsdatum 19/06/2024

Job Title - Statistical Programming Associate Director

Career Level - E

Location: Bangalore, India

Register your interest for a Statistical Programmer role within our Respiratory and Immunology group

Competitive salary and benefits

Play a critical role in making our pipeline accessible to patients.

Do you have expertise in, and passion for, SAS Programming? Would you like to apply your skills to impact all phases of drug development and regulatory interactions, in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

AstraZeneca is a global, Biopharmaceutical business that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.

Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying, and even curing some of the world’s most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world.

We work on some of the most complex and interesting challenges. A fast-paced and agile team, we are empowered and trusted to innovate and experiment. With access to our extensive capabilities and comprehensive pipeline, you’ll be involved in countless submissions and a wide range of engaging projects along the complete drug development process.

Main Duties and Responsibilities

In this role, we will give you the chance to utilize your statistical programming expertise in analysis and reporting of clinical trials and exploratory analyses to manage and generate evidence to support our product portfolio.

What You'll Do

  • Lead Statistical programming deliverables for regulatory submissions, including specification and delivery of datasets, outputs and response to regulatory questions, commercialisation, and reimbursements.
  • Lead delivery of the Clinical Study Report (CSR), Study Data Tabulation Model (SDTM)/Analysis Data Model (ADaM) databases and Tables, Figures and Listings (TFL) outputs through both internal and external delivery models, following applicable data standards and regulations
  • Lead Statistical programming contribution to Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Investigators brochures (IB)
  • Contribute to or lead the statistical programming thinking, analysis and reporting to relevant groups in product and study teams
  • Lead development of standard methodology to improve quality, efficiency, and effectiveness.
  • Drives standards development, implementation, and measure compliance to them
  • Provides inputs to capacity management while supporting recruitment and skill development by providing training and mentorship
  • Employ good project management practices (estimation, risk management, status tracking) when planning and leading delivery
  • Hold CRO/Partners accountable for the high-quality standards of their deliverables.

Essential Requirements

You are focused on solving challenging problems through collaboration and partnerships. You are a specialist in your field, or aspire to be a specialist, and you know that the best results are achieved by utilising the strengths of every individual.

  • Degree in Mathematics (i.e., Applied Math, Engineering, etc.), Computer Science, Statistics, Life Sciences, or similar area.
  • Extensive experience in clinical drug development or healthcare
  • Advanced SAS Programming, CDISC standards knowledge and industry best practices
  • Excellent interpersonal skills

Desirable for the Role

  • Experience working in the Respiratory or Immunology therapeutic area
  • Other programming languages e.g., S-PLUS, R, Python, XML etc.
  • Extensive knowledge of Pinnacle21 Validator

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

  • Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
  • Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.

Where can I find out more?



50056672 E CDPR

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