Senior Statistical Programmer

Job Title: Senior Statistical Programmer II

Introduction to role

Are you ready to make a difference in the world of rare diseases? As a Senior Statistical Programmer II at Alexion, you'll be at the forefront of developing and validating programs that create datasets conforming to Alexion and CDISC standards. You'll lead projects, develop specifications, and ensure adherence to ICH guidelines and regulatory requirements. Acting as a mentor, you'll guide Statistical Programmers and external consultants, integrating statistical concepts with SAS Programming efficiently. This role offers the opportunity to work independently while collaborating with cross-functional teams to drive innovation and excellence in statistical programming.

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

• Experience supporting HR processes and transactions, ideally in Workday
• Keen attention to detail and focus on data accuracy
• Understanding of common HR and service center enabling technologies e.g. case management, telephony and online user portals
• Able to communicate fluently in English
• Demonstrated ability to run meaningful tasks efficiently and prioritize workload within a matrixed team environment
• Experience in Microsoft applications
• Highly developed communications, organization and interpersonal skills
• Ability to work with confidential data
• Experience of delivering against Service Level agreements, including working with third party providers to meet work deadlines
• Ability to think analytically and optimally problem tackle using creative solutions
• Flexibility and resourcefulness to change

Desirable 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 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.

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's Alexion division, 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 enjoy the entrepreneurial spirit of a leading biotech while being supported by a global biopharma's resources. Join us in a culture that values diversity, inclusiveness, and the power of connection to patients' lived experiences.

Ready to make a difference? Apply now to join our team!

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 accommodations@Alexion.com. Alexion participates in E-Verify.