Project Lead Biostatistician

Project Lead Biostatistician

Germany/ France

Jonathan Cunliffe at Umbilical Life is sourcing for a Biostatistician with experience in clinical trials and ideally early phases. The client is a renowned Pharmaceutical looking to build the team due to the success and growth of the business.

I would like to speak to talented individuals who wish to be an integral part of an exciting world class team - ensuring quality across all programs. For a confidential conversation call Jonathan Cunliffe on +49 3221 421 9777.

Responsibilities

• You will form part of international project teams (eg, clinical, pharmacovigilance, regulatory affairs, marketing), contribute to the early development strategy and the management of the project.
• You will be responsible for the methodological and statistical aspects of projects as well as preparation of the associated submission dossier and decision-making.
• In interaction across several therapeutic units, coordinating the statisticians in charge of the different studies from the protocol to the study report.
• Close collaboration to integrate the translational strategy into development plans and implement it.
• Actively participate in writing clinical study synopsis/protocols, interpreting statistical analyses, and presenting results
• Participate in meetings with regulatory authorities; prepare submission dossier
• Provide/develop statistical expertise within the team, department or cross-functions with pharmacology, pharmacokinetics or pharmacometry teams.
• Innovate designs, analyses and, more broadly, the efficiency and effectiveness of the department through.

Requirements & Qualifications

• PhD or MSc in mathematics /statistics or related field.
• Statistician with significant experience in the pharmaceutical industry ideally in the field of early clinical studies.
• Experience in biomarker development, Phase IIb/III and submission would be appreciated
• High proficiency of clinical research and business strategy in this field; mastery of general regulatory guidelines, and specific to at least one therapeutic area
• Ability to understand clinical, regulatory and marketing issues and propose innovative/state-of-the art development plans, trial designs and analyses
• High proficiency of statistics used in the pharmaceutical industry in clinical development including statistical methods used for flexible designs as well as simulation technics; modelling and biomarker data mining skills
• Experience as a project manager; strong organization and coordination skills; leadership, including supervision of others.
• Familiar with state of the art study designs and statistical methods
• Very good communication skills and good popularization skills for explaining the statistical methods used
• Good level of English mandatory for writing and speaking; experience in presentations
• Very good skills in SAS ; practice of R
• Autonomous in the management of your activities; organized, able to efficiently manage multiple and variable deadlines

For a confidential conversation, contact Jonathan Cunliffe at Umbilical.