Principal Programmer - Statistical Programming

Job Title: Principal Programmer - Statistical Programming

Introduction to role:

Are you ready to take on a pivotal role in statistical programming As a Principal Statistical Programmer youll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications. Your expertise will drive the creation of Tables Listings and Figures for efficacy data analysis ensuring adherence to ICH guidelines Good Clinical Practices and regulatory requirements. Youll lead programming efforts represent Clinical and Statistical Programming in meetings and mentor fellow programmers. This is your chance to integrate statistical concepts with SAS Programming efficiently and effectively!

Accountabilities:

• Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards.
• Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications.
• Develop and validate technical programming specifications for protocol-specific efficacy tables listings figures/graphs based on Protocol SAP.
• Independently develop and validate programs that generate efficacy tables listings figures/graphs using Alexion specifications.
• Supervise/manage external vendors and contract programmers.
• Oversee progress of programming activities.
• Review maintain and approve protocol-specific documents as necessary.
• Provide guidance and mentoring to peer and junior-level Programmers.
• Act as the primary department contact when necessary to ensure 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:

• Bachelors Degree (Minimum) or Masters Degree (Preferred) in Biostatistics Statistics or another related discipline
• Minimum of 7 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
• Expertise in using SAS/Base SAS/Macro SAS/STAT.
• Knowledge of SAS/Graph and SAS/SQL
• Knowledge of:
• SDTM and ADaM
• Relational Databases.
• Good Clinical Practices.
• Good Programming Practices.
• 21CFR Part 11 Standards.
• Integrated Summary Safety/Efficacy Analyses.
• Safety data and Coding Dictionaries (MedDRA and WHODD).
• ICH eCTD format.

At AstraZeneca we play an essential role in helping patients who need it the most. Our high exposure roles allow us to shape end deliverables while embracing global opportunities across all Therapy Areas. With a restless drive for improvement we foster an inspiring learning environment where every setback is a chance to innovate. Our courageous team speaks up shares opinions and makes bold decisions that could change patients lives. We combine specialist knowledge with curiosity always searching for better ways to achieve the best results. Here dedication and motivation are key as we navigate unknowns with resilience.

Ready to make an impact 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 lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (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 aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in E-Verify.