Biostatistician (Sr to Principle)
Planet Pharma
USCanada
3d ago

SUMMARY

As a Senior level Biostatistician, you’ll have the opportunity to represent as our primary contact with our sponsors, applying knowledge of statistics to independently provide statistical consulting, assist with study design and protocol development, and performs statistical analysis of clinical trials.

You’ll review project related documents, prepare statistical analysis plans (SAPs) and statistical reports. You will also develop analysis data specifications, create analysis datasets, Tables, Listings and Graphs (TLG) of clinical trial data using SAS.

In this role, you’ll perform quality control of TLGs and derived data sets created by others, as well as develop and validate SAS programs, macros, and utility tools.

You’ll also have the unique opportunity to work on NDA submissions to engage with studies at the program level preparing Clinical Summaries of Safety (ISS) and Efficacy (ISE).

What you’ll be doing :

  • Independently utilize your respected expertise to provide statistical consulting
  • Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications
  • Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents
  • Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses
  • Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions
  • Independently prepare analysis data specifications
  • Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS
  • Perform quality control of analysis data and TLGs
  • Review and provide input in interpreting analysis result to clinical study report
  • Background to be Considered :

  • Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years
  • or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience

  • Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation / management algorithms
  • Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
  • Detail oriented, well organized with the ability to work on several projects simultaneously
  • Excellent team player, collaborative and maintains a positive, results-orientated work environment
  • Accountable, dependable and demonstrates strong commitment to the role
  • Is customer service focused in approach to work, both internally and externally
  • Requirements : Background to be Considered :

  • Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years
  • or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience

  • Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation / management algorithms
  • Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
  • Detail oriented, well organized with the ability to work on several projects simultaneously
  • Excellent team player, collaborative and maintains a positive, results-orientated work environment
  • Accountable, dependable and demonstrates strong commitment to the role
  • Is customer service focused in approach to work, both internally and externally
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