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Principal Biostatistician

Location: 

Raleigh, North Carolina, United States

Job Function:  Clinical Development
Job ID:  65090

Principal Biostatistician

UCB Biosciences

Raleigh, NC

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?

 

Job Summary  

  • Serving as a Biostatistician Study Lead, responsible for driving statistical input in one or more individual clinical studies within a clinical program or across multiple clinical programs. Providing expert guidance on study design and appropriate statistical input on all aspects of analysis, interpretation of findings and reporting of results. Giving technical and strategic oversight of deliverables outsourced to external CRO’s or vendors. Producing and reviewing statistical deliverables for a submission or other regulatory interactions.
  • Performing exploratory statistical analysis to gain novel insight that can be used to help inform the development of existing or new compounds.  The role will require the Principal Biostatistician to work effectively with other cross-functional teams within and outside SSI
  • Pro-actively driving and delivering statistical excellence to non-clinical development in Preclinical and Research areas, ensuring decision-making takes place within the parameters set by logical and quantitative scientific inference. 
  • Actively driving innovation within the team and, transversally across SSI. Act as ambassador for SSI, representing the department internally and externally. Works within a Global team.
  • Seeks information from the internal and external environment to understand the wider business, scientific and/or commercial context.

 

 

Major Accountabilities

  • 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 Project Lead Statistician 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.

 

Education and Qualification

  • PhD with 5+ years of experience
  • Master’s degree with 7+ years of experience
  • 5-7 years of biostatistics experience within the Biotechnology and/or Pharmaceutical Industry (including clinical research organizations) or relevant academic role with proven successful track record in pharmaceutical development.

 

Competencies

  •  Able to serve as a principal statistical expert in SSI and across functions.
  • Excellence in a variety of relevant statistical methodologies, for example Bayesian approaches.
  • Excellent communication and presentation skills.
  • Good knowledge of SAS and/or R programming.
  • Excellent knowledge in visualization and simulation techniques.
  • Excellent written and verbal communication skills in English.
  • 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.
     

To apply please go to www.ucb.com/careers.

Discover more about the remarkable UCB Talent Blends and how you can contribute to the mix at www.ucb.com/careers.


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