Our expanding Programming team is looking for an experienced Senior Manager to lead the team.
Who are we?
We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field.
Why should you join Avance Clinical?
We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.
We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.
The Senior Manager, Statistical Programming is responsible for planning and executing or overseeing projects by coordinating staff and processes to deliver projects on time, within budget and with the desired outcomes while ensuring the trial is conducted in accordance with the protocol, company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements.
Core Responsibilities
• Provide technical leadership and oversight for statistical programming deliverables, ensuring high-quality, compliant datasets, tables, listings, and figures through effective cross-functional collaboration and adherence to CDISC standards, regulatory requirements, and internal SOPs.
• Analyse study protocols, statistical analysis plans, and sponsor requirements to translate business and research needs into technical programming specifications.
• Develop, modify, and validate SAS programs to generate clinical datasets, tables, listings, and figures (TLFs) in accordance with CDISC SDTM and ADaM standards.
• Perform unit testing, debugging, validation, and documentation of statistical programs to ensure data integrity and reproducibility.
• Maintain and enhance existing programming codebases, implementing improvements to efficiency, reliability, and standardisation.
• Collaborate with Biostatistics, Data Management, PK, Clinical Operations, and Medical Writing teams to ensure technical consistency, accurate data flow, and timely delivery of programming outputs.
• Identify, analyse, and resolve programming defects, performance issues, and data inconsistencies throughout the project lifecycle.
• Ensure all programming activities comply with internal SOPs, regulatory requirements, and applicable quality standards.
• Contribute to the development, maintenance, and optimisation of programming macros, utilities, libraries, and tools to support scalable and reusable solutions.
• Participate in peer code reviews and quality checks to ensure adherence to technical standards and best practices.
• Support audit and inspection activities by providing technical explanations, programming documentation, and validated outputs as required.
• Provide technical guidance and knowledge sharing to colleagues on programming methodologies, standards, and tools, as needed.
• Perform other programming-related duties as directed by the Line Manager.
Departmental Responsibilities
• Collaborate effectively with members of the Biometrics department to support integrated technical delivery of clinical data outputs.
• Identify and mitigate technical risks related to statistical programming deliverables.
• Participate in technical training and continuous professional development related to programming tools, standards, and methodologies.
• Contribute to continuous improvement initiatives relating to programming processes, standards, and automation.
• Manage sponsor communication, project timelines, risks, and programming-related resources, including forecasting, change control, and issue resolution, to ensure successful and timely project delivery.
Qualifications, Skills and Experience
• Bachelor’s degree in Computer Science, Information Technology, Software Engineering, or a related quantitative discipline.
• Minimum 5 years of hands-on programming experience, with the majority of time spent writing, testing, and maintaining code.
• Demonstrated expertise in SAS programming, including development of SDTM and ADaM datasets.
• Strong experience in application-style programming logic, data processing workflows, and system optimisation.
• Proven ability to analyse requirements and translate them into technical solutions.
• Experience working within regulated environments and adhering to documented standards and procedures.
• Strong problem-solving, debugging, and analytical skills.
What we offer