Senior Statistical Programmer II

Job Title: Senior Statistical Programmer II

Career Level: D

Introduction to role

The Senior Statistical Programmer II will be a primary resource for the development and validation of programs that create datasets conforming to Alexion and CDISC standards, as well as Tables, Listings, and Figures (“TLFs”) for analysis purposes. Depending on the size and complexity of a study, they may act as the lead programmer for the project. They will develop specifications to ensure that statistical programming elements align with the overall deliverable and ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. They may represent Statistical Programming in meetings with internal and external clients and cross-functional project teams. The Senior Statistical Programmer will also mentor Statistical Programmers and external consulting resources. They must demonstrate a strong ability to integrate statistical concepts with SAS Programming efficiently and effectively and be able to work independently.

Accountabilities

• Support development of technical programming specifications for SDTM, ADS, or ADaM standards.
• Independently develop and/or validate programs that generate SDTM and analysis datasets based on Alexion or ADaM specifications.
• Support development and validate technical programming specifications for tables, listings, figures/graphs based on Protocol and SAP.
• Independently develop and validate programs that generate tables, listings, figures/graphs using Alexion specifications.
• Manage external vendors and contract programmers.
• Provide project progress updates of programming activities.
• Review, maintain, and approve protocol-specific documents as necessary.
• Provide guidance and mentoring to peer, junior-level Programmers, and contract staff.
• Support project leadership ensuring that department standards are implemented in all studies.
• Contribute ideas and thoughts towards the optimization of standard operating procedures.
• Lead team meetings when appropriate.
• Any other activities as required.

Essential Skills/Experience

• Minimum of 6 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
• Proven ability to:
• Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs.
• Independently and collaboratively resolve problems
• Clearly communicate processes and standards with management and team members
• High competence in using SAS/Base, SAS/Macro, SAS/STAT.
• Knowledge of SAS/Graph, and SAS/SQL
• Knowledge and implementation of:
• SDTM and ADaM principles
• Relational Databases
• Good Clinical Practice principles
• Good Programming Practice principles
• 21CFR Part 11 Standards principles
• Integrated Summary Safety/Efficacy Analyses
• Safety data and Coding Dictionaries (MedDRA and WHODD)
• ICH eCTD format

Desirable Skills/Experience

NA

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Joining Alexion means embracing an opportunity where work isn’t ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and each other. Combined with our brave, pioneering spirit – we are truly unique in R&D and healthcare. At Alexion, grow and innovate in a business with a rapidly expanding portfolio. Enjoy the entrepreneurial spirit and autonomy of a leading biotech. You’ll join an energizing culture where people build connections to explore new ideas and learn. As an important member of our team, you'll meet the needs of some of the most under-served patients in the world. You will be empowered with tailored development programs designed not just for skill enhancement but for fostering a deep understanding of our patient's journeys.

Ready to make an impact? Apply now!

Date Posted

Closing Date

AstraZeneca 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.