Senior Statistical Programmer

This is what you will do:

The Senior Statistical Programmer will be a primary resource for the development and validation of programs which build datasets conforming to Alexion and CDISC standards, as well as Tables, Listings, and Figures (“TLFs”) for analysis purpose.  They will develop specifications to ensure that statistical programming elements are in line with the overall deliverable and ensure alignment to 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 multi-functional project teams.  The Senior Statistical Programmer will act as a mentor to Statistical Programmers and Associate Statistical Programmers. They must demonstrate, at a minimum, a proven ability to accurately integrate statistical concepts with SAS Programming in a most efficient and effective manner.

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.
• 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.

The duties of this role are generally conducted in an office environment.  As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; problem tackle; engage in sophisticated and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

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.
  • Coordinated Summary Safety/Efficacy Analyses.
  • Safety data and Coding Dictionaries (MedDRA and WHODD).
  • ICH eCTD format.

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.