Senior Biostatistician

INTRODUCTION

DICE is a CRO specialized in Biometrics and more specifically in clinical study design, data management, biostatistics and medical writing. DICE was established in 1989 and services biotech start-ups as well as big pharma companies mainly in interventional studies across the globe. DICE is renowned for delivering excellent quality and is involved in innovative projects. We differentiate by our highly skilled staff, bio statistical knowledge and drive to deliver the best quality to our customers.

As a result of our growth, DICE is seeking to employ a Senior Biostatistician.

SENIOR BIOSTATISTICIAN

Key accountabilities

As a Bio-statistician you are responsible for the statistical design and analysis of clinical studies, in line with regulatory guidelines from ICH, FDA, EMA and others. The tasks to be performed are:

• Statistical design of clinical studies: sample size, adaptive designs, statistical methodologies tailored to study design and objectives, estimands, endpoints and statistical considerations
• Interactions with authorities on statistical aspects of the study: scientific advice, submissions, D-120, D-180 questions.
• Redaction of statistical analysis plans
• Participation to DSMB and other trial committees
• QC of Statistical analysis of clinical trials (efficacy, safety, integrated analysis, Module 2, Module 5, …)
• Single point of contact for all statistical aspects of a clinical study

You will be part of a multidisciplinary team that supports biotech companies across the globe in early development programs.

Key competencies

• Eye for detail
• Independent
• Customer focus
• Excellent communication skills including with senior stakeholders
• Integrity and trustworthiness

Key requirement

This position requires:

Education

• A health or science related Master Level University degree in a numerate field: statistics or biostatistics, mathematics, physics, engineer or similar

Experience

• Minimum 7 years of experience as a biostatistician
• Sound knowledge of relevant regulatory guidelines
• Proven experience with interactions with senior stakeholders at the sponsor level: CMO, CSO,…
• Proven experience with interactions with competent authorities: EMA, FDA and others.

Skills/Know How

• Excellent verbal and written skills in English
• Sound knowledge of regulatory guidelines and statistical concepts used in clinical research, ICH guidelines, EMA and FDA guidelines
• Programming skills in SAS, R and/or Python
• Can do attitude and the flexibility to engage in a variety of tasks and projects
• Background in a medical field is a plus
• Eagerness to learn and to continuously develop

We offer the opportunity to develop within a growing company with a strong focus on personal development, flexible work conditions and a competitive compensation package.

Interested?

Send your application to:

recruitment@dice-cro.com or apply directly through the linked platform.