Statistical Programmer II
Vor 6 Tagen
The Regulatory Start Up Associate II / SRSA is primarily responsible for planning, preparation, review of country and site level ethics and regulatory authority applications and submissions during project start-up, in compliance with ICH‑GCP and local regulatory requirements, to ensure timely clinical trial approval. This role will be based in Australia and we offer hybrid working arrangements (2 days in the office). Responsibilities Serve as the primary point of contact for the Regulatory Start‑Up Manager (RSM) and / or Project Manager (PM) during start‑up on allocated projects. Provide expertise and guidance to RSM and / or PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries. Work within the scope of the Regulatory Start‑Up plan or other applicable project plan, relevant SOPs, and ICH‑GCP. Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate. Works within forecasted submission / approval timelines and ensures they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions / approvals. May serve as a point of contact with investigative sites for Regulatory Authority, Ethics Committees / Review Boards and other local authority related activities. Minimum Qualifications & Experience Graduate in a clinical, pharmacy or life sciences related field. At least 1 year of related experience in either a CRO, pharmaceutical or clinical / hospital environment in Australia. Confident English written and verbal communication style. Ability to work across multiple IT applications and databases. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. #J-18808-Ljbffr
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Statistical Programmer II | AU based
vor 1 Woche
Council of the City of Sydney, Österreich Novotech VollzeitAbout the Role The Statistical Programmer II is primarily responsible for undertaking all statistical programming tasks on one or more clinical studies under the supervision of more senior Statistical Programmers and/or Statistical Programming Management. The SP II works closely with the project biostatisticians and other project stakeholders to plan and...
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Council of the City of Sydney, Österreich Novotech VollzeitA leading research services company in New South Wales is seeking a mid-senior level Statistical Programmer II to undertake statistical programming tasks within clinical studies. The role involves reviewing study protocols, programming datasets, and providing mentorship to junior programmers. Applicants should have a Bachelor's degree in a relevant field and...
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Clinical Statistical Programmer
vor 2 Wochen
Council of the City of Sydney, Österreich i-Pharm Consulting Vollzeit2 days ago Be among the first 25 applicants Direct message the job poster from i-Pharm Consulting Recruiting Clinical Operations, Clinical Project Management & Biometrics Professionals across Australia and New Zealand | EDI Champion ANZ Opportunity for an experienced Statistical Programmer to join an independent CRO. You will be a part of a small biometrics...
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Statistical Programmer/Senior Statistical Programmer
vor 4 Wochen
Council of the City of Sydney, Österreich Southern Star Research VollzeitOverview Southern Star Research is a leading, privately owned Australian Contract Research Organisation (CRO) headquartered in Sydney. We specialise in delivering high-quality clinical research services to clients across the pharmaceutical, medical device, and biotechnology sectors throughout Australia, New Zealand, and the Asia-Pacific region. We value...
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Statistical Programmer
vor 2 Wochen
City of Melbourne, Österreich Xprt Dev VollzeitSenior & Principal Statistical Programmer (SAS) | Clinical Trials | Remote Australia Ready to own complex programming for global studies while still having real influence in a tight‑knit team? This permanent role is ideal for experienced Clinical SAS Programmers who want technical depth, autonomy, and direct impact on oncology development. The Company...
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Senior Statistical Programmer I
Vor 4 Tagen
City of Melbourne, Österreich Avance Clinical VollzeitSenior Statistical Programmer I Avance Clinical 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 's. If you already work in this industry you'll know...
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City of Melbourne, Österreich Avance Clinical VollzeitA Contract Research Organization is seeking a Senior Statistical Programmer. The role involves preparing clinical study reports and ensuring quality control of CDISC datasets. Candidates should have at least 2 years of experience in statistical programming and strong knowledge of CDISC. The position offers a flexible workplace, project diversity, and...
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Senior Statistical Programmer – Cdisc
vor 8 Minuten
City of Melbourne, Österreich Avance Clinical VollzeitOverview A Contract Research Organization is seeking a Senior Statistical Programmer. Responsibilities The role involves preparing clinical study reports and ensuring quality control of CDISC datasets. Qualifications Candidates should have at least 2 years of experience in statistical programming and strong knowledge of CDISC. Benefits The position offers a...
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Senior Statistical Programmer
vor 4 Minuten
City of Melbourne, Österreich Avance Clinical VollzeitA Contract Research Organization is seeking a Senior Statistical Programmer to prepare clinical study reports and ensure the quality control of CDISC datasets. Candidates should have a minimum of 2 years of statistical programming experience and strong knowledge of CDISC. This position offers a flexible workplace, project diversity, and professional growth...
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Council of the City of Sydney, Österreich Avance Clinical VollzeitA Contract Research Organisation in New South Wales is seeking a Senior Statistical Programmer I to provide clinical programming expertise in the production of tables, figures, and listings for clinical study reports. The successful candidate will have at least 2 years of relevant experience, strong CDISC knowledge, and proficiency in SAS programming. The...
