Associate Director - Statistical Programming

Job Title: Associate Director - Statistical Programming

Introduction to role

Are you ready to lead and innovate in the world of statistical programming? As the Associate Director of Statistical Programming, you will oversee programming activities for multiple clinical studies, ensuring compliance with SOPs and delivering quality results on time. With your extensive SAS expertise and understanding of CDISC SDTM and ADaM standards, you'll support Biostatistics in generating analysis data listings, tables, and figures. Your strong people management skills will be crucial as you provide direct line management to statistical programmers and manage external partners. Are you prepared to make a significant impact?

Accountabilities

• Serve as the Lead Programmer and Manager of statistical programming efforts.
• Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards.
• Independently develop and validate programs for analysis datasets based on specifications.
• Develop and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs.
• Ensure study documentation is maintained to audit standards.
• Support the Clinical and Statistical Programming Director in managing the Statistical Programming team.
• Participate in reviewing processes to ensure compliance and updates.
• Create/review programming plans and ensure resource allocation.
• Act as the primary department contact for implementing standards in studies.
• Manage adherence to company policies, SOPs, and departmental standards.
• Collaborate with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions.

Essential Skills/Experience

• 7+ years statistical programming experience in the CRO or Pharmaceutical Industry.
• 4+ years project management experience in the CRO or Pharmaceutical Industry.
• Experience with CDISC SDTM and ADaM models and transforming raw data into those standards.
• Strong people management skills and supervisory skills gained from direct line management or supervisory experience. Proven abilities to lead and manage cross-functional projects, and people, from concept to completion.
• Strong verbal and written communication skills - ability to clearly and effectively present information.
• An excellent understanding of the roles and responsibilities of all related disciplines, in particular Biostatistics, Clinical Data Management, and Pharmacovigilance.
• Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures.
• Extensive experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate analysis datasets, tables, listings, and figures/graphs.
• Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle.
• Advanced experience with:
• Constructing technical programming specifications.
• Relational Databases.
• Good Clinical Practices.
• Good Programming Practices.
• 21CFR Part 11 Standards.
• Integrated Summary Safety/Efficacy Analyses.
• Creating all files necessary to support an electronic submission in the eCTD format.

Desirable Skills/Experience

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

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 directly impacts patients' lives. With a culture that encourages exploration and learning, you'll be part of a team that values diversity and inclusion. Our entrepreneurial spirit combined with global resources offers a unique opportunity to grow your career while making a difference.

Ready to take the next step? 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.