Principal Biostatistician

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.

www.i-pharmconsulting.com

• 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.