Senior Clinical Research Analyst

Job Description

We are seeking a Biostatistics Professional to drive clinical development and analysis with advanced statistical methods.

The ideal candidate will be embedded within a global pharmaceutical client, providing support for innovation in patient treatment.

This role involves leading Phase II-III clinical studies across your region, motivating teams to great work, and collaborating easily with clients.

Key responsibilities include statistical input into study protocols, Case Report Forms, data management plans, DMCs, writing statistical analysis plans, reviewing or creating analysis dataset specifications, and performing statistical analyses.

The successful candidate will author study documents incorporating the Estimand framework, create specifications, and perform analyses such as time-to-event and longitudinal analysis.

This role also involves reviewing and contributing to study reports, clinical and statistical sections of regulatory submission dossiers, leading electronic submissions to regulatory authorities.

You will manage biostatisticians and statistical programmers, generate innovative statistical methodologies, contribute internally and externally to company visibility through expertise and customer orientation.

A strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management is essential.

The ideal candidate should have a PhD in statistics or master's degree in statistics or related subject, along with clinical trial experience.

Candidates with relevant experience in statistical or biostatistical analysis supporting clinical trial operations for the pharma / biotech industry are preferred.

Understanding of application of biostatistics to medical / clinical trials data, excellent verbal and written communications skills, ability to organize multiple work assignments and establish priorities are key qualities required for this role.

Familiarity with SAS & CDISC knowledge is required, while experience in R / R Shiny is preferred. Late Phase (II or III) experience and experience with regulatory submissions are also advantageous.