Principal Statistical Programmer

Introduction to role:

Are you ready to make a significant impact in the world of biopharmaceuticals? As a Principal Statistical Programmer, you'll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications. Your expertise will drive the analysis of efficacy data through Tables, Listings, and Figures (TLFs). You'll ensure compliance with ICH guidelines, Good Clinical Practices, and regulatory requirements while leading programming efforts and representing Clinical and Statistical Programming in meetings with internal and external clients. As a mentor to other Statistical Programmers, you'll integrate statistical concepts with SAS Programming efficiently and optimally.

Accountabilities:

• Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards.
• Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications.
• Build and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs based on Protocol SAP.
• Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications.
• Supervise/manage external vendors and contract programmers.
• Be responsible for progress of programming activities.
• Review, maintain, and approve protocol-specific documents as vital.
• Provide guidance and mentoring to peer and junior-level Programmers.
• Act as the primary department contact to ensure implementation of department standards in all studies.
• Contribute ideas towards the optimization of standard operating procedures.
• Lead team meetings when appropriate.
• Engage in any other activities as required.

Essential Skills/Experience:

• Bachelor’s Degree (Minimum) or Master’s Degree or equivalent experience (Preferred) in Biostatistics, Statistics or another related field
• Minimum of 7 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
• Expertise in using SAS/Base, SAS/Macro, SAS/STAT.
• Knowledge of SAS/Graph, and SAS/SQL

Desirable Skills/Experience:

• SDTM and ADaM
• Relational Databases.
• Good Clinical Practices.
• Good Programming Practices.
• 21CFR Part 11 Standards.
• Integrated Summary Safety/Efficacy Analyses.
• Safety data and Coding Dictionaries (MedDRA and WHODD).
• ICH eCTD format.

At AstraZeneca's Alexion division, you'll find a unique opportunity to work in a company where 'Here it means more' is an ethos that drives us. Our pioneering spirit in R&D and healthcare sets us apart, allowing you to grow and innovate within a rapidly expanding portfolio. You'll be part of an energizing culture that fosters connections, exploration of new ideas, and learning. As a member of our team, you'll meet the needs of under-served patients worldwide while being empowered with tailored development programs. Our dedication to diversity, innovation, and connection to patients' lived experiences ensures your career journey is impactful.

Ready to make a difference? Join us at AstraZeneca's Alexion division today!

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. Alexion participates in E-Verify.