Job Description

Job Title - Statistical Programming Associate DirectorCareer Level - ELocation: Bangalore, IndiaRegister your interest for a Statistical Programmer role within our Respiratory and Immunology groupCompetitive salary and benefitsPlay 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 worlds most serious disease. But were more than one of the worlds 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 worlds 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, youll be involved in countless submissions and a wide range of engaging projects along the complete drug development process.Main Duties and ResponsibilitiesIn 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 RequirementsYou 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 were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres 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. Were on an exciting journey to pioneer the future of healthcare.So, whats next?

• Are you already imagining yourself joining our team? Good, because we cant 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 its yours.

Where can I find out more?

• Our Social Media, Follow AstraZeneca on LinkedIn
• Follow AstraZeneca on Facebook
• Follow AstraZeneca on Instagram
• Our dedicated Biometrics page

Date Posted 18-Sept-2024Closing Date 30-Oct-2024AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca