Job Description

Sr. Statistical Programmer IIWhen 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 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.The Senior Statistical Programmer will be a key resource for developing and validating programs that create datasets adhering to Alexion and CDISC standards, as well as Tables, Listings, and Figures (TLFs) for analysis purposes. They will develop specifications to ensure that statistical programming elements align with the overall deliverable and comply with ICH guidelines, Good Clinical Practices, and regulatory requirements. They will support the Programming Lead and may represent Statistical Programming in meetings with internal and external clients and cross-functional project teams. Additionally, the Senior Statistical Programmer will mentor Statistical Programmers and Associate Statistical Programmers. They must demonstrate a strong ability to effectively integrate statistical concepts with SAS Programming.You will be responsible for:

• 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.
• Oversee external vendors and contract programmers.
• Provide updates on the progress of programming activities.
• Review, maintain, and approve protocol-specific documents as needed.
• Offer guidance and mentorship to peers, junior programmers, and contract staff.
• Support project leadership to ensure department standards are applied across all studies.
• Contribute ideas for optimizing standard operating procedures.

You will need to have:

• Minimum of 4 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 principals
• Relational Databases.
• Good Clinical Practice principals.
• Good Programming Practice principals.
• 21CFR Part 11 Standards principals.
• Integrated Summary Safety/Efficacy Analyses.
• Safety data and Coding Dictionaries (MedDRA and WHODD).
• ICH eCTD format.

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.#LI-HybridAstraZeneca 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.

Alexion Pharmaceuticals