Senior or Principal Biostatistician_United States

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Date: Jun 29, 2019

Location: Raleigh, North Carolina, US

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

Senior or Principal Biostatistician: US, UK, Germany or Belgium
UCB – Inspired by patients. Driven by science.
Help us transform patients’ lives.

 

About UCB
Everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” And to find the answers, we connect globally with patients and their families living with the physical and social burdens of severe disease. These connections give us new perspectives, drive our innovation, and offer a hope for a new generation of therapies that will help to transform lives. 

To strengthen our Statistical Sciences and Innovation Group, we are looking to fill the position of: Senior or Principal Biostatistician.

 

About the Role
You will be responsible for:

 

Clinical
•    Acts as the lead biostatistician for one or more clinical studies within a clinical program or across multiple clinical programs. 
•    Gives input into the study design, efficacy and safety parameters and the planned statistical analyses. Performs simulations to support choice of study design, decision rules and the sample size. Participates in protocol development if this is not delegated to an external partner biostatistician. Reviews and approves the protocol prepared by the external partner biostatistician. 
•    Supports or overseas external partner biostatistical support for all statistical operational aspects of the clinical trial, covering trial set up, trial delivery and the readout of results.  This includes input into randomization specifications, statistical analysis plans, interim analyses, safety reviews and final analyses.
•    Communicates and coordinates all statistical activities with external partner biostatisticians. Ensuring the implementation of global, program and SSI standards by all biostatisticians contributing to the project.
•    Provides input on interpretation of results by attending and presenting at the Results Interpretation Meeting (RIM). Reviews and inputs into the clinical study report. 
•    Assists the biostatistician lead for a program of studies with the statistical deliverables for regulatory submissions and the lifecycle of a development compound.
•    Principal Biostatistician can serve as a biostatistician lead for a program of studies, as agreed to by their line manager.

 

Pre/Non-Clinical
•    Ensure that scientific questions for research objectives are defined clearly and that data collection, statistical methods and analyses are optimally designed to provide statistical evidence to answer those questions in alignment with project objectives.  
•    Provide insight on the risk associated to a decision.
•    Ensure non-clinical assays/analysis for compounds in development are fit for purpose and coordinate, the planning of these statistical deliverables in alignment with the project’s development plan. 
•    Be deeply involved in the continuous development of the statistical expertise and improvement of the quality and compliance of the support given by SSI to the New Medicines department.
•    Establish/implement solutions for standardisation within the team and at business.

 

About You
You should have/be able to:
•    5+ (with PhD) to 7+ (with Master’s degree) years in biostatistics within the Biotechnology and/or Pharmaceutical Industry or relevant academic role with proven successful track record in pharmaceutical development. 
•    Excellence in a variety of relevant statistical methodologies, including Bayesian approaches.
•    Good knowledge of SAS and/or R programming.
•    Excellent knowledge in visualization and simulation techniques.
•    Able to work under pressure and without supervision.
•    Able to drive and influence teams to ensure evidence-based decisions are made
•    Able to provide training of statistical topics to biostatisticians and to explain statistics topics in a non-technical manner to non-statisticians.
•    Able to adapt to change.
•    Able to travel both, domestically and internationally, as business necessitates
•    Contributes to an environment of mutual confidence and co-operation among the team and with the research and development partners.
 

 

UCB is a global biopharmaceutical company. We focus on discovering and developing innovative medicines and lateral solutions that can transform the everyday lives of people with severe diseases of the immune system – or the central nervous system.

With more than 7500 people in approximately 40 countries, UCB offers an exciting working environment where initiative can flourish and those with a ‘can-do’ attitude can thrive.  Scientific excellence, innovation, co-creation, lateral thinking, reinventing the way we do things…these are some of the key competencies we are constantly developing, and looking for, at UCB.


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