Job Opportunity: Senior Statistical Programmer at Alexion Pharmaceuticals

Date Posted: 12-Jun-2024
Closing Date: 24-Jul-2024

Job Description

Alexion Pharmaceuticals is looking for a highly skilled Senior Statistical Programmer. In this role, you'll play a crucial part in developing and validating programs to build datasets conforming to Alexion and CDISC standards, as well as creating Tables, Listings, and Figures (TLFs) for analysis purposes. You will also ensure alignment with ICH guidelines, Good Clinical Practices, and regulatory requirements.

Key Responsibilities

• Develop technical programming specifications for SDTM, ADS, or ADaM standards.
• Independently develop and validate programs generating SDTM and analysis datasets based on Alexion or ADaM specifications.
• Support the development and validation of technical programming specifications for tables, listings, and figures/graphs based on protocols and SAP.
• Manage external vendors and contract programmers.
• Provide project progress updates on programming activities.
• Review, maintain, and approve protocol-specific documents as necessary.
• Mentor Statistical Programmers and Associate Statistical Programmers.
• Support project leadership to ensure department standards are implemented in all studies.
• Contribute to the optimization of standard operating procedures.
• Lead team meetings when appropriate.

Work Environment

The duties of this role are typically performed in an office environment. Employees must be able, with or without accommodation, to:

• Use a computer.
• Engage in communications via phone, video, and electronic messaging.
• Problem-solve and engage in complex and non-linear thought processes.
• Collaborate effectively with others.
• Maintain general availability during standard business hours.

Qualifications

To be considered for this role, you must have at least 4 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.

Required Skills:

• Proven ability to develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs.
• Ability to independently and collaboratively resolve problems.
• High competence in using SAS/Base, SAS/Macro, SAS/STAT, with 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
  • Coordinated Summary Safety/Efficacy Analyses
  • Safety data and Coding Dictionaries (MedDRA and WHODD)
  • ICH eCTD format

About Alexion Pharmaceuticals

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where everyone can feel valued for their uniqueness. We do not make employment decisions based on race, color, religion, creed, sex, sexual orientation, age, ancestry, national origin, marital status, pregnancy, parental status, military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness, or other protected characteristics.

Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue regarding an accommodation, please contact .

Alexion participates in E-Verify.

How to Apply

If you are an experienced and motivated Senior Statistical Programmer, we invite you to apply today and join our innovative team at Alexion Pharmaceuticals.