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Senior Statistical Programmer
hace 3 meses
Location:
Barcelona, Spain
Competitive salary and benefits
Play a critical role in making our pipeline accessible to patients.
Would you like to be a part of a Programming group, who has direct strategic impact on drug development, playing a key role in getting medicines to patients?
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.
If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
Our 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.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.
Role
You will provide statistical programming support and/or leadership of activities related to the analysis and reporting process including, but not limited to, clinical study report development, regulatory submissions, commercialisation and the scientific utilisation of our data for AstraZeneca products.
There are many career options you can pursue for progression including technical pathways, management of global projects or line management.
You'll be part of a distributed team that pulls together to put patients first.Responsibilities
Reporting to a Director within the R&I Programming group you will provide programming expertise in one or more of the following areas:
- 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
- Statistical programming deliverables for regulatory submissions, including specification and delivery of pooled safety/efficacy databases, outputs and response to regulatory questions, commercialisation and reimbursements
- Contribute to the development of standard process to improve quality, efficiency and effectiveness of the Programming group
- Statistical programming contribution to Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER) and Investigators brochures (IB)
Requirements:
To succeed in this role, you'll be an enthusiastic individual with an understanding of technical and regulatory requirements related to programming within the pharmaceutical or healthcare industry.
Desirable experience includes:
- Excellent problemsolving skills
- Diligence attention to detail and ability to manage concurrent projects and activities
- Excellent verbal and written communication skills and ability to influence partners
- SAS programming expertise gained within a clinical drug development or healthcare setting
- Knowledge of CDSIC standards and industry best practices
- Knowledge of database setup and the clinical trial analysis and reporting process
- Team centric approach: keen to take steps to understand and appreciate the roles, skills and strengths of others on the team
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.
Onsite position
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines.
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