Sr Statistical Programmer I

Job Title: Sr Statistical Programmer I

Career Level: D

Introduction to role

Are you ready to make a significant impact in the world of rare disease biopharma As a Senior Statistical Programmer I at Alexion you will be a key player in developing and validating programs that create datasets conforming to Alexion and CDISC standards. Your work will include generating Tables Listings and Figures (TLFs) for analysis purposes. You will ensure adherence to ICH guidelines Good Clinical Practices and regulatory requirements. Supporting the Programming Lead you may represent Statistical Programming in meetings with internal and external clients and crossfunctional project teams. Additionally you will mentor Statistical Programmers and external consulting resources demonstrating a strong ability to integrate statistical concepts with SAS Programming efficiently and effectively. Independence is crucial in this role.

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 protocolspecific documents as necessary.
• Provide guidance and mentoring to peer juniorlevel 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 4 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 principles
• Relational Databases
• Good Clinical Practice principles
• Good Programming Practice principles
• 21CFR Part 11 Standards principles
• Integrated Summary Safety/Efficacy Analyses
• Safety data and Coding Dictionaries (MedDRA and WHODD)
• ICH eCTD format
• Integrated Summary Safety/Efficacy Analyses

Desirable Skills/Experience

• 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 lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 we are driven by our passion to innovate and create meaningful value in all we do. Our commitment to patients living with rare diseases inspires us to push boundaries and translate complex biology into transformative medicines. With a rapidly expanding portfolio we offer an entrepreneurial spirit combined with the resources of a global biopharma. Join us to make a difference where it truly counts.

Ready to make an impact Apply now!

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 EVerify.