Late Development Statistician – 6 month contract – UK or Remote

Reference: RS180221A

Expiry Date: 19-04-2021

Categories Biotech, Clinical Research

Salary: Competitive

Job Type: Contractor

Location:
London
Greater London
United Kingdom

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Job Description

Late Development Statistician – 6 month contract – UK or Remote

Global Biopharma is seeking late development statisticians, Roles can be based remotely from UK, Europe or US. Contract is inside IR35 (Uk Applicable).

Description:

The job responsibilities for a Contract Biostatistician may include:

  • Serving as a statistical study lead, responsible for driving statistical input in one or more individual clinical studies within a clinical program or across multiple clinical programs. Providing guidance on study design and appropriate statistical input on all aspects of analysis, interpretation of findings and reporting of results. Giving technical 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 biostatistician to work effectively with cross-functional teams within and outside SSI
  • As applicable, 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.
  • Create value by working collaboratively with teams within and across therapeutic areas, to deliver appropriate support and fit for purpose approaches across the Client project portfolio. Actively driving innovation within the team and, transversally across SSI. Works within a Global team.
  • Seeks information from the internal and external environment to understand the wider business, scientific and/or commercial context.

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 the protocol prepared by the external partner biostatistician.
  • Supports or oversees 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 possibly 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.
  • Effectively contributes within cross-functional or multi-disciplinary groups
  • Stays current with ongoing developments in statistical methods applications in the pharmaceutical industry.
  • Acts as a resource for other biostatisticians in SSI
  • Communicates complex issues in nontechnical language by using visuals, simulations and other illustrative techniques.
  • Provides statistical sciences training to  employees from different disciplines on statistical concepts.
  • Contributes and reviews abstracts, posters, presentations and manuscripts for publication and ensures accuracy of all biostatistical aspects of such documents
  • Adheres to the company SOPs and working procedures.

If interested please contact me ASAP to discuss.

To Apply!

To apply for this role, please contact me, the Clinical & Medical Hiring Lead, asking for Roland Schnapka, on +44 (0)207 801 3387 or send a full CV to roland@advtalent.com. Alternatively, please press the red “Apply for position” button and follow the registration process.

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