At a Glance
- Tasks: Lead programming efforts to create datasets and analyse efficacy data in biopharmaceuticals.
- Company: Join AstraZeneca's Alexion division, a leader in R&D and healthcare innovation.
- Benefits: Enjoy tailored development programs, a diverse culture, and the chance to impact global health.
- Other info: Be part of a pioneering team that values innovation and connection.
- Why this job: Make a difference for under-served patients while growing in a supportive and energising environment.
- Qualifications: Bachelor’s or Master’s in Biostatistics/Statistics with 7+ years of programming experience required.
The predicted salary is between 48000 - 72000 £ per year.
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Job Title: Principal Statistical Programmer
Introduction to role:
Are you ready to make a significant impact in the world of biopharmaceuticals? As a Principal Statistical Programmer, you\'ll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications. Your expertise will drive the analysis of efficacy data through Tables, Listings, and Figures (TLFs). You\'ll ensure compliance with ICH guidelines, Good Clinical Practices, and regulatory requirements while leading programming efforts and representing Clinical and Statistical Programming in meetings with internal and external clients. As a mentor to other Statistical Programmers, you\'ll integrate statistical concepts with SAS Programming efficiently and optimally.
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.
- Build 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.
- Be responsible for progress of programming activities.
- Review, maintain, and approve protocol-specific documents as vital.
- Provide guidance and mentoring to peer and junior-level Programmers.
- Act as the primary department contact to ensure implementation of department standards in all studies.
- Contribute ideas towards the optimization of standard operating procedures.
- Lead team meetings when appropriate.
- Engage in any other activities as required.
- Bachelor’s Degree (Minimum) or Master’s Degree or equivalent experience (Preferred) in Biostatistics, Statistics or another related field
- 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
- 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.
Ready to make a difference? Join us at AstraZeneca\'s Alexion division today!
Seniority level
Seniority level
Associate
Employment type
Employment type
Full-time
Job function
Job function
Research, Analyst, and Information TechnologyIndustries
Pharmaceutical Manufacturing
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#J-18808-LjbffrPrincipal Statistical Programmer in Cambridge employer: AstraZeneca Plc
At AstraZeneca's Alexion division, we pride ourselves on being an exceptional employer that champions innovation and personal growth. Our dynamic work culture encourages collaboration and exploration, allowing you to make a meaningful impact in the biopharmaceutical industry while supporting under-served patients globally. With tailored development programs and a commitment to diversity, you'll find ample opportunities for professional advancement in a supportive environment that values your contributions.
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We think you need these skills to ace Principal Statistical Programmer in Cambridge
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