Job Opportunity: Associate Director of Statistical Programming

Company Name: Alexion Pharmaceuticals

Job Title: Associate Director, Statistical Programming

What You Will Do

The Associate Director of Statistical Programming will oversee statistical programming activities for multiple clinical studies, maintain programming infrastructure, and ensure compliance with SOPs for quality and timely results. You must have extensive experience with SAS in a Statistical Programming environment and thorough knowledge of statistical programming processes and procedures.

You will apply your expertise in CDISC SDTM and ADaM standards to support Biostatistics in generating analysis data listings, tables, and figures, and in building files required for electronic submission in eCTD format. Additionally, you'll leverage your strong people management skills to manage and train statistical programmers, identify training needs, and optimize staff utilization and practices.

You Will Be Responsible For:

• Serving as the Lead Programmer and Manager of statistical programming efforts.
• Developing and validating technical programming specifications for analysis datasets using Alexion or ADaM standards.
• Independently developing and validating programs generating analysis datasets based on Alexion or ADaM specifications.
• Creating and validating technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs.
• Maintaining the filing of study documentation to required audit standards.
• Supporting the Clinical and Statistical Programming Director in managing and developing the Statistical Programming team.
• Reviewing and updating processes used by the Statistical Programming group.
• Developing and reviewing programming plans and ensuring appropriate prioritization.
• Acting as the primary department contact to ensure implementation of department standards.
• Managing adherence to company policies, SOPs, and other controlled documents.

You Will Need To Have:

• 7+ years of statistical programming experience in the CRO or Pharmaceutical Industry.
• 2-5 years of people and project management experience.
• Experience with CDISC SDTM and ADaM models.
• Strong people management and supervisory skills.
• Proven ability to lead and manage cross-functional projects and people.
• Strong verbal and written communication skills.
• Understanding of roles and responsibilities in Biostatistics, Clinical Data Management, and Pharmacovigilance.
• Proficiency in SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a Windows environment.
• Experience in developing and validating analysis datasets, tables, listings, and figures/graphs using SAS within a Statistical Programming environment.
• Knowledge of clinical database design and electronic data capture using Inform, Medidata, and Oracle.
• Experience with constructing technical programming specifications and Relational Databases.
• Familiarity with Good Clinical Practices, Good Programming Practices, 21 CFR Part 11 Standards, and Coordinated Summary Safety/Efficacy Analyses.
• Ability to craft files required for electronic submission in eCTD format.

We Would Prefer For You To Have:

• BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics, or a related area.
• Proficiencies in Accountability, Teamwork, Decision Quality, Drive for Results, Perseverance, Problem Solving, Informing, Peer Relationships, Time Management, Building Effective Teams, and Managing Through Systems.

Date Posted: 12-Jun-2024

Closing Date: 24-Jul-2024

Equal Employment Opportunity

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 belong because of their uniqueness. Decisions about employment, training, compensation, promotion, and other terms and conditions of employment are based on merit, not race, color, religion, sex, sexual orientation, age, ancestry, national origin, citizenship status, marital status, pregnancy, military status, protected veteran status, disability, gender identity, 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