TRIAL STATISTICIAN

Job title.
Trial Statistician Location.
Remote (or onsite depending on proximity to office) Permanent/Full – time Are you interested in working for a biotech which is in an exciting phase of growth and dedicated to creating therapies to improve the lives of patients around the world? Then this is the role for you! Responsibilities Author the Statistical Sections of Protocol.
Propose and Review the Study design.
Calculate the sample size.
Review the Case Report Form (CRF).
Author Statistical Analysis Plan (interim and final as appropriate).
Perform the Statistical Analysis (Efficacy and Safety (key safety like Adverse Events)) using SAS or R.
Provide Statistical Consultancy on an ongoing basis for projects.
Write the specifications for the efficacy analysis.
Review the Specifications for the Safety Analysis.
Work Collaboratively with the data management, Clinical Operations, Medical Writing and the Pharmacovigilance team as appropriate.
Provide inputs to the regulatory affairs for discussions with the health authorities (e.
.
ANSM, EMA, FDA).
Review the Clinical Study Report and provide statistical inputs as appropriate.
Perform exploratory analysis as appropriate.
Requirements Masters in Statistics or equivalent with minimum 5 relevant pharmaceutical (or CRO) industry work experience.
PhD in Statistics highly desirable.
Good Knowledge of SAS or R.
Good Understanding of CDISC Concepts.
Good understanding of ICH guidelines.
Fluent in English.
What this role / company promises.
Organisational support to balance work and personal life Excellent compensation and benefits Flexible work arrangements (i.
.
when and where you work) Challenging & impactful work Interested? drop me an email with your CV.