Experience:
No experience
Employment Type:
Full time
Posted:
10/2/2017
Job Category:
Information Services
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Lead Statistical Analyst - Job #9598
Bayer U.S. LLC | Newark, New Jersey
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Job Description

Job #9598

Lead Statistical Analyst

Your tasks and responsibilities

Bayer U.S. LLC’s Whippany, NJ, office seeks a Lead Statistical Analyst to lead statistical programming and validation activities for all clinical study/integrated programming requests in close collaboration with study/integrated statistical team.

The primary responsibilities of this role, Lead Statistical Analyst, are to: 

  • creating or contributing to SAP, study/integrated TLF and ADS specs;
  • preparing statistical programming deliverables for submissions and globally health authority question responses, HEOR, Medical Affairs, Marketing, and other functions within the organization;
  • strong partnering with study/project/compound/integrated statisticians and statistical programming teams to ensure use of compound/project standards;
  • cross-communicating with other cross functional team members ensuring consistency within study standards and definitions;
  • ensuring compliance with End to End process within a clinical study;
  • oversight of projects/studies by external vendors; and 
  • leading the cross functional study execution team and/or study statistical analyst team.

 

Who you are

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

  • Bachelor's degree (or foreign equivalent) in Statistics, Computer Science, Applied Mathematics, or a related field
  • 10 years of post-baccalaureate and progressively responsible experience in a related position
  • project management within statistical programming global function;
  • leading or managing resources or a global team;
  • experience in several different TAs especially in Cardio Vascular;
  • leading the effort to continuously improve processes to conform to evolving industry standards and participating in the ongoing review and development of quality systems and processes, including CDISC implementation (SDTM and ADaM mapping);
  • supporting HAQ from U.S. FDA and/or other health authorities globally including EMA, PMDA, CFDA etc. and preparing responses to agency questions as well as negotiating with other functions regarding deliverables and timelines;
  • certified in advanced SAS programming and knowledgeable in Base SAS, SAS/STAT, SAS Macro language ,SAS SQL and R language as well as programming in NDAs with eCTD formatted NDA submissions;
  • statistics (like regression and correlation analysis);
  • relevant regulatory guidelines and standards (e.g., FDA, ICH and EMEA); (ix) prioritizing and managing multiple projects simultaneously;
  • managing and leading programmers in India and/or China; 
  • post marketing trials and medical affairs support;
  • must be able and willing to travel domestically and internationally up to 20%.

Web Id: 29502


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