Senior Statistical Programmer II – Early Phase

Job Title: Senior Statistical Programmer II – Early Phase

Career level: D

Introduction to role:

Are you ready to make a difference in the world of medicine? As a Senior Statistical Programmer II - Early Phase, you'll be at the forefront of statistical programming activities for early phase studies across various therapeutic areas. You'll ensure compliance with SOPs, maintain programming infrastructure, and produce quality deliverables. Whether leading projects or collaborating with biostatisticians and programming teams, your expertise will be crucial in developing oversight plans and ensuring adherence to regulatory requirements. You'll mentor others, integrate statistical concepts with SAS programming, and work independently to drive success.

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:

• 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, you'll find an environment where your expertise is valued and visible. We thrive on innovation, constantly seeking new ways to improve and make a tangible difference in patients' lives. Our collaborative approach allows us to harness diverse perspectives, pushing boundaries to achieve groundbreaking solutions. With countless learning opportunities across global therapy areas, you'll have the chance to grow both personally and professionally while contributing to research that impacts society worldwide.

Ready to take on this exciting challenge? Apply now to join our dynamic 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.