Senior Statistical Programmer II

Job Title: Senior Statistical Programmer II

Career Level: D

Introduction to role

The Senior Statistical Programmer II will be a primary resource for the development and validation of programs that create datasets conforming to Alexion and CDISC standards as well as Tables Listings and Figures (TLFs) for analysis purposes. Depending on the size and complexity of a study they may act as the lead programmer for the project. They will develop specifications to ensure that statistical programming elements align with the overall deliverable and ensure adherence to ICH guidelines Good Clinical Practices and regulatory requirements. They may represent Statistical Programming in meetings with internal and external clients and crossfunctional project teams. The Senior Statistical Programmer will also mentor Statistical Programmers and external consulting resources. They must demonstrate a strong ability to integrate statistical concepts with SAS Programming efficiently and effectively and be able to work independently.

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 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 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

Desirable Skills/Experience

NA

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.

Joining Alexion means embracing an opportunity where work isnt ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and each other. Combined with our brave pioneering spirit we are truly unique in R&D and healthcare. At Alexion grow and innovate in a business with a rapidly expanding portfolio. Enjoy the entrepreneurial spirit and autonomy of a leading biotech. Youll join an energizing culture where people build connections to explore new ideas and learn. As an important member of our team youll meet the needs of some of the most underserved patients in the world. You will be empowered with tailored development programs designed not just for skill enhancement but for fostering a deep understanding of our patients journeys.

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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.