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Biostatistician with SAS Programming II

Swiftwater, PARandstad LifeSciences


Chat with me now! - https://flashrecruit.com/jobs/300051
 

Job Title:  Biostatistician with SAS Programming II


Job Summary

  • Provide statistical support to other statisticians through the management of tasks at the trial level

  • This individual will provide statistical expertise to support the research and development of our products. He/she will provide critical input on the design and analysis of our clinical trial data so that accurate assessments are made for decision-making. 

  • This individual will have to use his/her technical expertise to make the appropriate decision concerning which method to use for analyzing data. He/she will also have to provide a critical review to ensure the correctness of results for accurate decision-making. He/she will have to work in a multidisciplinary team and will have to effectively communicate to team members who may not have the same training. 

  • We operate in a highly regulated environment; therefore, we must ensure that our work is of the highest quality and will withstand the scrutiny of regulatory agencies around the world. This individual must possess the ability to work on several different projects that are at different stages while managing the details is highly important. 

Job Responsibilities

  • With supervision by a more senior statistician or head of Biostatistics, produces synopsis, statistical section of the protocol, and SAP for specific studies            
  • Participates in programming activities (analysis files, TLFs, randomization, …)
  • With supervision by a more senior statistician or head of Biostatistics, completes the statistical section of the iCSR
  • Reviews and approves study-related documents (CRFs, DEPs, …)     
  • With supervision by a more senior statistician or head of Biostatistics, computes sample sizes, discuss trial design, and creates randomization
  • In collaboration with the programmers, ensures that statistical programs are developed, tested and validated prior to the target analysis date.

Education & Qualifications

  • Ph.D. in Biostatistics or related field with at least 2 years (Masters with at least 4 yrs) of Pharmaceutical or vaccines industry experience.
  • 3-6 years of relevant experience

  • Statistical Analysis

  • Experience in filing BLAs or NDAs a plus

  • Good SAS programmer with SAS macros experience

  • Ability to support Phase I - III studies (mainly phase II/III)

  • Ability to work on multiple studies at one time 

  • Excellent oral and written communication skills

  • Good presentation skills

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

 


Chat with me now! - https://flashrecruit.com/jobs/300051