Statistical Programmer

6 months ago

Bengaluru, India AstraZeneca Full time

**Career level C**

**Statistical Programmer**

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

**AstraZeneca** is a global, science-led, patient-oriented biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. 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.

Our **Late **Stage Development R&I Biometrics** team is dedicated to the development of innovative treatment of **Respiratory and Immunology (R&I)** diseases. You will join a global, diverse and cross-functional environment where you will get personal and professional development.

**ABOUT THE ROLE**:
The Senior Statistical Programmer role is responsible for programming deliverables in compliance with Good Clinical Practices, with the required time and quality, and, according to established standards and processes. This position requires advanced technical skills and thorough industry knowledge to independently perform programming tasks while using judgment about seeking guidance in complex situations. The Senior Statistical Programmer will be expected to lead programming deliveries of clinical studies, projects in a collaborative and cross-functional environment and lead cross-functional teams to deliver continuous improvement.

**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 Statistical programming deliverables for 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 deliverables for Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Investigators brochures (IB)
- Contribute to the statistical programming thinking, analysis and reporting to relevant groups in product and study teams
- Contribute to the development of standard methodology to improve quality, efficiency and effectiveness
- Measure compliance to standards and automation use
- 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.
- 6-11 years of work experience with Degree in Mathematics (i.e., Applied Math, Engineering, etc.), Computer Science, Statistics, Life Sciences or similar area
- Strong 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 Pinnacle 21 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 ho

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