Warman O’Brien·26 days ago
26 days ago
Principal Statistician - 6527
Sign up free to see how well your resume matches this role.
What you'll do
- Acting as Lead Biostatistician across clinical studies, development programmes and regulatory submissions.
- Managing day-to-day statistical activities and ensuring work is delivered accurately and on time.
- Providing statistical input into study design, protocols and clinical development strategy.
- Developing, reviewing and approving statistical analysis plans.
- Reviewing and approving statistical sections of clinical study reports and other regulatory documents.
- Overseeing statistical deliverables and supporting interactions with clients and regulatory authorities.
- Providing statistical consultancy across a range of therapeutic areas and study designs.
- Supporting research proposals, project budgets and statistical scopes of work.
- Contributing to bid defence and prospective client meetings.
- Providing technical guidance and support to other statisticians within the team.
What they're looking for
- An MSc or PhD in Biostatistics, Statistics or a closely related discipline.
- At least nine years of relevant biostatistics experience with an MSc, or seven years with a PhD.
- Strong experience supporting clinical trials and the wider drug development process.
- Experience leading statistical activities across multiple clinical studies or programmes.
- Advanced knowledge of statistical methodology, programming practices and clinical trial reporting.
- The ability to review and approve protocols, statistical analysis plans and clinical study reports.
- Experience supporting regulatory submissions or interactions with health authorities.
- Strong organisational skills and the ability to manage competing priorities.
- Confident written and verbal communication skills.
- Demonstrable leadership skills and the ability to guide more junior colleagues.
- Candidates must have the legal right to work in the country in which they will be employed.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Principal Biostatistician Locations: Czech Republic, Poland, Spain, Romania, Bulgaria or Hungary Working arrangement: Home-based Employment: Permanent Warman O’Brien is partnering with a leading global clinical research organisation to recruit an experienced Principal Biostatistician. This is an excellent opportunity to take statistical leadership across clinical studies and programmes while contributing to the development of innovative new medicines. The Role As Principal Biostatistician, you will lead the statistical delivery of individual studies, programmes of work and regulatory submissions. You will work closely with clients, clinical teams and regulatory stakeholders, providing expert statistical guidance throughout the clinical development process. Your responsibilities will include: Acting as Lead Biostatistician across clinical studies, development programmes and regulatory submissions. Managing day-to-day statistical activities and ensuring work is delivered accurately and on time. Providing statistical input into study design, protocols and clinical development strategy. Developing, reviewing and approving statistical analysis plans. Reviewing and approving statistical sections of clinical study reports and other regulatory documents. Overseeing statistical deliverables and supporting interactions with clients and regulatory authorities. Providing statistical consultancy across a range of therapeutic areas and study designs. Supporting research proposals, project budgets and statistical scopes of work. Contributing to bid defence and prospective client meetings. Providing technical guidance and support to other statisticians within the team. Your Experience To be considered, you should have: An MSc or PhD in Biostatistics, Statistics or a closely related discipline. At least nine years of relevant biostatistics experience with an MSc, or seven years with a PhD. Strong experience supporting clinical trials and the wider drug development process. Experience leading statistical activities across multiple clinical studies or programmes. Advanced knowledge of statistical methodology, programming practices and clinical trial reporting. The ability to review and approve protocols, statistical analysis plans and clinical study reports. Experience supporting regulatory submissions or interactions with health authorities. Strong organisational skills and the ability to manage competing priorities. Confident written and verbal communication skills. Demonstrable leadership skills and the ability to guide more junior colleagues. Candidates must have the legal right to work in the country in which they will be employed. What’s on Offer Competitive base salary and performance-related incentives. Flexible, home-based working. Comprehensive health and wellbeing benefits, subject to location. Pension or retirement provision. Life assurance and disability coverage. Employee assistance and wellbeing programmes. Structured training and long-term career development opportunities. The opportunity to work on international clinical development programmes within a highly regarded global organisation. Benefits may vary depending on the country of employment. Interested? To find out more or arrange a confidential discussion, please contact: Aimee Weston Principal Consultant – Biometrics Warman O’Brien aimee@warmanobrien.com
Company
Warman O’Brien
Hungary
Company facts come from this company's own listings. We only show what the postings themselves carry.