Senior Statistical Programmer II

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Job Title: Senior Statistical Programmer II

Career Level: D

Introduction to role:

Are you ready to take on a pivotal role in the development and validation of programs that create datasets conforming to Alexion and CDISC standards? As a Senior Statistical Programmer II, you will be at the forefront of crafting Tables, Listings, and Figures (TLFs) for analysis purposes. Depending on the project's size and complexity, you may lead programming efforts, ensuring alignment with ICH guidelines, Good Clinical Practices, and regulatory requirements. You'll also have the opportunity to mentor fellow programmers and represent Statistical Programming in meetings with internal and external clients. Are you prepared to integrate statistical concepts with SAS Programming efficiently and effectively?

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.

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.

At AstraZeneca, you'll find an environment where innovation thrives. Our commitment to rare diseases means your work will have a profound impact on patients' lives. With a rapidly expanding portfolio, you'll have the chance to grow alongside a team that values diversity, inclusiveness, and the power of connection. Here, your career is more than just a path—it's a journey towards making a meaningful difference.

Ready to make an impact? Apply now to join our team!
Seniority level Seniority level Associate
Employment type Employment type Full-time
Job function Job function Research, Analyst, and Information Technology
Industries Pharmaceutical Manufacturing
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