Hobson Prior are working with a world-wide healthcare organisation whose products and services are used to help care for patients who are critically ill. Our client is looking for a Director of Statistics to provide statistical expertise from study design to post-marketing activities for clinical and high-level CMC activities in compliance with regulatory requirements.
- Provide statistical input to the development plans, concept sheets, protocols, Clinical Study Reports, Briefing Books, ISS/ISE, submission package, interactions with Health Authorities.
- Accountable for the oversight of Statistical Analyses Plans, review of SDTM/adam packages, and other statistical deliverables.
- Deliver input for detailed timelines forecasting.
- Pro-actively contribute to the strategic development of biosimilars.
- Estimate internal resources for biostatistics/programming oversight tasks.
- Review CRO statistics/programming deliverables.
- Manage budget related to statistical/programming tasks.
- Subject Matter Expert for audits and inspections.
- Manage and troubleshoot operational challenges, GCP compliance, and standardization in collaboration with cross functional colleagues.
- Effectively collaborate with all Biostatistics and Data Management colleagues for input and information exchange to facilitate best practices across all studies/programs.
- Partake actively in CRO selection process.
- Work effectively with cross-functional management teams and external partners. Interact proactively and solution orientated with other clinical and non-clinical functions.
- Develop, review, update, and add sops as company/situations evolve when applicable.
- Excellent communication skills (verbal, written, and presentation).
- Highly motivated and enjoys working in a fast-paced environment.
- Strong organizational skills and the ability to prioritize and multi-task.
- Positive, flexible self-starter who thrives under pressure.
- Excellent judgment and problem-solving skills.
- Master's degree (or equivalent) or PhD in Statistics, Biostatistics or related discipline.
- You will have 12+ years of related industry experience within the functional area.
- Strong SAS expertise.
- Excellent knowledge of ICH and other relevant guidance documents (from FDA, EMA, …).
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.