Statistical Programmer
Vor 2 Tagen
Be a part of an Award Winning Global CRO based in Australia03rd December, 2024Who 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.Core Responsibilities• Translate study protocol and Statistical Analysis Plan into algorithms and specifications to achieve analysis and CDISC standards.• Create and/or validate all safety and efficacy study output requirements (e.g. SDTM, ADaM, TLFs) consistent with data definitions and specifications and relevant study documentation (e.g. protocol, SAP, aCRF).• Manage and maintain programming specifications for SDTM, ADaM, analysis dataset, analysis outputs, and integration of data in support of ISS/ISE.• Review and provide input to Case Report Forms (CRFs) and External Data Review Transfer Agreements.• Management of project specific programming tasks and deliverables to ensure project team will provide statistical programming deliverables according to project timelines.• Provide accurate programming time estimates and risk mitigation plans to Management or Project Team.• Identify study priorities and communicate effectively with project team and management.• Ensure quality, proper documentation and meet or exceed timely completion of the project within budgeted hours.• Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design.• Actively participate in study team meetings.• Provide accurate and timely responses to routine requests from clients and with limited supervision responses to non-routine requests from clients.• Responsible for identifying opportunities for productivity improvements and formulating proposal for new SAS utilities/macros and their implementation.• Ensuring programming is conducted according to departmental and industry standards.• Responsible for developing and maintaining good client relationships.Departmental Responsibilities• Effectively understand, complete trainings, and implement all SOPs, Guidelines, and Work Instructions.• Mentor junior level statistical programmers by developing training plans and providing oversight of their work.• Work independently, exercise good judgment in interpreting, modifying, and adapting company standards, project specifications, tasks, and goals.• Knowledge of pharmaceutical clinical development (i.e. understanding of safety deliverables and efficacy analysis supporting regulatory submissions).• Knowledge of base SAS, proc report, exposure to macros, current CDISC data structures, and standardization methodology; demonstrated ability to debug SAS programs.• High degree of technical competence in SAS Macro programming, SAS SQL, XML, RTF, and PDF.• Demonstrated teamwork, pride of ownership, accountability, problem-solving and innovative skills.• Reflect company culture through actions, attitude, and work.Qualifications, Skills and Experience• Minimum 3-5 years' experience in statistical programming in pharmaceutical / health research.• Strong CDISC knowledge and SDTM conversion experience.• Experience with development, documentation, and testing of analysis data and programming code to meet regulatory and company standards.• Knowledge of ICH GCP Guidelines, medical terminology and clinical trials processes.• Excellent time management and organisational skills.• Demonstrated initiative, trust and reliability and the ability to work unsupervised.• Excellent verbal and written communications skills.• Willingness to work in, and be supportive of, a positive and dynamic team culture.• Base and Advanced SAS Certification is an added advantage.
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