About iNGENū CRO:
iNGENū is the FDA-centric Australian CRO championing disruptive, innovative US and global biotech firms. We are physician-led, providing access to the full spectrum of clinical and nonclinical research services.
Our core mission is to create access to high quality clinical research globally, for early to mid-stage biotechs by removing financial and other unnecessary barriers.
About the role:
Reporting into the Senior Vice President for Clinical Data & Biometrics, the Senior Statistical Programmer will play a critical role in supporting the design, development, and execution of statistical analysis plans for clinical trials and research studies.
Your extensive knowledge of CDISC standards and proficiency in SAS programming will be essential in ensuring the accurate representation and analysis of clinical trial data for iNGENu CRO. You will collaborate closely with cross-functional teams across the organization, including but not limited to the Clinical Data and Clinical Operations teams to ensure the timely delivery of high-quality programming solutions.
Responsibilities:
- Develop and validate SAS programs to transform clinical trial data into SDTM and ADaM datasets, adhering to CDISC standards and programming specifications.
- Collaborate closely with cross-functional teams, including clinical data managers, statisticians, and medical writers, to ensure seamless data integration and analysis.
- Design and implement CDISC-compliant data structures and define standard variables to facilitate efficient data submission and regulatory compliance.
- Conduct quality control checks on SDTM and ADaM datasets, ensuring accuracy, consistency, and adherence to CDISC standards.
- Generate tables, listings, and figures (TLFs) using SAS programs for statistical analysis and clinical trial reporting.
- Provide expertise and guidance on CDISC implementation, SDTM mapping, ADaM dataset creation, and associated documentation.
- Collaborate with internal teams and external vendors to harmonize data across multiple studies or databases and ensure consistency in SDTM and ADaM standards.
- Stay updated with the latest CDISC standards, regulatory requirements, and industry best practices related to SDTM, ADaM, and clinical trial data management.
- Participate in the development and maintenance of programming standards, templates, and macros to enhance efficiency, consistency, and quality in SAS programming activities.
- Contribute to the development of data validation plans, data review guidelines, and data quality checks to ensure accurate and reliable analysis results.
Skills & Experience:
- Bachelor’s or Master’s degree in a relevant field (e.g., Statistics, Computer Science, Bioinformatics) or equivalent experience.
- Five to ten years’ experience with SAS programming in a CRO with the last 4-5 years specialising in CDISC (SDTM and ADaM).
- Familiarity with other programming languages such as R or Python.
- Strong proficiency in SAS programming language, including SAS/Base, SAS/STAT, SAS/Macro, and SAS/Graph.
- Extensive experience in programming clinical trial data using SDTM and ADaM standards.
- Solid understanding of CDISC standards, including SDTM and ADaM implementation guidelines and controlled terminology.
- Proven expertise in SDTM mapping, ADaM dataset creation, and associated documentation (e.g., define.xml).
- In-depth knowledge of clinical trial data management processes, including CRF design, data capture, and data cleaning.
- Familiarity with regulatory guidelines (e.g., FDA, ICH) and industry best practices related to SDTM, ADaM, and clinical trial programming.
- Experience in generating tables, listings, and figures (TLFs) using SAS programming for clinical trial reporting.
- Strong problem-solving and troubleshooting skills, with a keen attention to detail and data accuracy.
- Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
- Excellent communication skills, including the ability to communicate complex technical information to non-technical stakeholders.
- Strong analytical skills, with the ability to identify issues, develop solutions, and make data-driven recommendations.
- Full Working Rights in Australia