Senior Statistician

OPIS

Remote

The Senior Statistician reports to the Biostatistics Coordinator, serve as primary point of contact to the study team for statistical related matters, liaises with external stakeholders and ensure clinical data are analyzed in compliance with applicable standards, regulatory guidelines and OPIS SOPs. The Senior Statistician provide the study team and the Sponsor with advices 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- Contribute to the design of clinical studies providing appropriate statistical methodology;
Review the study objectives and endpoints with the study team andor 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 designreview the study CRF, to define protocol deviations, edit checks and other data quality controls;
Develop SAS programs andor 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 acts as a mentor for junior staff.

What we are looking for:

Degree in Statistics (or equivalent degree) with a specialization in medical or epidemiological statistics;
At least 3 year 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;
English language fluent;
Planning and organizational skills;
Communication skills;
Team-working oriented.