Due to our ongoing global expansion, we have a great opportunity for a Senior Statistician to join our growing team, on a fully remote basis.

The Senior Statistician reports to the Biostatistics Coordinator, serves as the primary point of contact to the study team for statistical related matters, liaises with external stakeholders, and ensures clinical data are analyzed in compliance with applicable standards, regulatory guidelines, and OPIS SOPs. The Senior Statistician provides the study team and the Sponsor with advice on statistical methodology and study design and acts as a mentor for junior staff.

What you'll do:

• Be responsible for all statistical activities regarding the assigned clinical studies, e.g. study design, sample size estimation, analysis plan, analysis populations, statistical analyses and reporting.
• Work independently with minimal support from the Head of Biostatistics Unit and contribute to the design of clinical studies providing appropriate statistical methodology.
• Review the study objectives and endpoints with the study team and/or the Sponsor and write detailed statistical analysis plan (SAP).
• Generate randomization lists or random selection procedures and collaborate with the Data Manager to produce the related documentation.
• Collaborate with the Data Management team to design and review the study CRF, to define protocol deviations, edit checks, and other data quality controls.
• Develop SAS programs and/or collaborate with the SAS programmer to generate analysis datasets, mock shells, TFLs for reporting and publications.
• Perform the quality control of deliverables generated by other statisticians or SAS programmers.
• Write the Statistical Report and/or the statistical sections of the Clinical Study Report.
• Track activities and milestones to ensure timely project deliverables.
• Liaise with Sponsor and external stakeholders regarding statistical activities and results of statistical analyses.
• Present and share knowledge at team meetings.
• Collaborate in establishing and maintaining SOPs related to Biostatistics.
• Organize/perform trainings for project team and act as a mentor for junior staff.

• Degree in Statistics (or equivalent degree) with a specialization in medical or epidemiological statistics.
• At least 3 years of experience in CRO, biotech, pharma, research institutes, or similar.
• Proven knowledge and expertise in statistics and its applications to clinical research.
• Solid knowledge and experience in drug development process and GCP guidelines.
• Solid knowledge of SAS and other statistical software packages.
• Experience in developing CDISC standard specifications and datasets (SDTM, ADaM).
• Knowledge of computer systems related to clinical trials (EDC, IVRS, IWRDS, EPRO, CTMS, etc.).
• Excellent communication and team-working skills.
• Strong commitment to quality.
• Proactive attitude and independence in organizing activities.
• Flexibility and propensity for innovation.
• Fluent in English.
• Planning and organizational skills.
• Communication skills.
• Team-working oriented.