Principal Biostatistician
- Melbourne, Victoria
- Permanent
Opportunity for an experienced Principal Statistician to join an independent CRO. You will be leading the Biometrics and Programming team, as well as implementing new strategies with senior management & CEO.
We are seeking the below:
Principal Statistician with strong SAS programming skills.
* Proven leadership experience - project/strategic leadership
* At least 5 years in a CRO setting.
OR
Principal Statistician
* Strong PK analysis - knowledge of WinNonlin is essential.
This company have a Biotech focus with multiple complex oncology (and other areas) projects coming up. They partner with ANZ companies and so offer more flexible working without late-nights or awkward time-zones.
This role would suit an experienced Principal Statistician with extensive CDISC and clinical trial knowledge, strong strategic mindset, and ability to lead sponsor meetings.
Responsibilities:
Working 100% remote, you will be responsible for:
- Collaborating with clients and internal teams to design clinical trials or research studies, including determining sample sizes, randomisation procedures, and statistical methodologies.
- Drafting SAPs outlining the statistical methods, analysis datasets, and programming specifications to ensure the validity and reliability of study results.
- Performing statistical analyses using appropriate software (e.g., SAS, R) to analyze clinical trial data, including efficacy and safety endpoints, and interpreting results for inclusion in study reports.
- Ensuring the accuracy and quality of statistical deliverables, including review of programming code, tables, figures, and listings (TFLs), and providing guidance to junior statisticians.
- Contributing to regulatory submissions (e.g., INDs, NDAs) by providing statistical input, reviewing statistical sections of documents, and participating in meetings with regulatory agencies.
- Serving as the primary point of contact for statistical issues with clients, presenting study results, and providing statistical consultation and support throughout the duration of the project.
- Providing guidance and mentorship to junior statisticians, fostering their professional development, and contributing to the growth and success of the biostatistics team
- Identifying opportunities to streamline processes, enhance efficiency, and improve the quality of statistical deliverables within the organisation
Skills:
- BSc in a scientific or related field.
- At least 5 year's experience statistics within the pharmaceutical industry.
- Clinical Trial experience (Phases I-III)
- CDISC experience (ADaM and SDTM datasets)
ABOUT i-PHARM CONSULTING
i-Pharm Consulting is a specialist Recruitment Company servicing the pharmaceutical industry in Europe, APAC, and North America. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.
- Title: Principal Biostatistician
- Location: Remote Australia
- Salary: $130,000 - $165,000 plus superannuation (open to negotiation)
Apply direct now, or send your updated CV to Keeley Munday at kmunday@i-pharmconsulting.com.
Associated Keywords: SAS, Programming, Statistical Programming, Clinical, Phases I-III, CRO, Pharma, Pharmaceutical, Research, Oncology, Cardiovascular, Respiratory, TFL, CDISC, SDTM, ADaM, Melbourne, Victoria.