Sr Statistical Programmer II

Sr. Statistical Programmer II

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 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.

The Senior Statistical Programmer will be a key resource for developing and validating programs that create datasets adhering to Alexion and CDISC standards as well as Tables Listings and Figures (TLFs) for analysis purposes. They will develop specifications to ensure that statistical programming elements align with the overall deliverable and comply with ICH guidelines Good Clinical Practices and regulatory requirements. They will support the Programming Lead and may represent Statistical Programming in meetings with internal and external clients and crossfunctional project teams. Additionally the Senior Statistical Programmer will mentor Statistical Programmers and Associate Statistical Programmers. They must demonstrate a strong ability to effectively integrate statistical concepts with SAS Programming.

You will be responsible for:

• 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.
• Oversee external vendors and contract programmers.
• Provide updates on the progress of programming activities.
• Review maintain and approve protocolspecific documents as needed.
• Offer guidance and mentorship to peers junior programmers and contract staff.
• Support project leadership to ensure department standards are applied across all studies.
• Contribute ideas for optimizing standard operating procedures.

You will need to have:

• 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 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.

At Alexion you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients lives.

Ready to lead and inspire Apply now and take the first step towards a fulfilling career at Alexion AstraZeneca Rare Disease.

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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.