A leading international pharmaceutical company has 2 urgent permanent Principal Biostatistician opportunities to be based in there head office in Switzerland.
KEY RESPONSIBILITIES:
- Responsible for all statistical tasks on the assigned clinical trials, and perform these tasks with a high level of independence. For example, clinical trial design/planning, regulatory interactions, analysis plan, reporting activities, CTD and summary documents, exploratory analyses, and statistical consultation.
- May be assigned to lead a small project or parts (e.g., indication(s)) of a project, initially under the supervision/guidance of a more experienced statistician but with increasing autonomy and accountability.
- Track clinical trial/allocated project activities and milestones.
- Interact with the Method group as appropriate.
- Ensure timelines and adequate quality of all Biostatistics and Statistical Reporting (B&SR) deliverables for the assigned trials and project tasks.
- Follow processes and adhere to the clients and project specific standards as well as Health Authority requirements (SOPs, Master Analysis Plan, full development project specifications, and regulatory guidelines).
- Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and B&SR team.
- Participate in or lead non-clinical project activities as needed.
Minimum requirements:
- Master Degree in Statistics (or equivalent degree) with at least 5 years of pharmaceutical experience or PhD in Statistics with at least 2-3 years of pharmaceutical experience
- Experience in all tasks of a Trial Statistician
- Experience in Oncology Statistics and/or regulatory activities would be advantageous
- Fluent English (oral and written)
- Proven knowledge and expertise in statistics and its application to clinical trials
- Proven knowledge of drug development and Health Authority guidelines
- Knowledge of statistical software packages (e.g. SAS, S+)
- Good communication and presentation skills
- Good team player
This job was posted 30+ days ago, and has expired.
