Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Lead Statistical Programmer/Analyst

Your tasks and responsibilities

Bayer U.S. LLC’s Whippany, NJ, office seeks a Lead Statistical Programmer /Analyst to lead statistical programming and validation activities for all clinical study/integrated programming requests as specified by the Statistician.

 

The primary responsibilities of this role, Lead Statistical Programmer/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, Life Sciences or a related field with 5 years of experience in the pharmaceutical or biotechnology industry.
  • demonstrated project management skills within statistical programming function;
  • experience in  Oncology TA;
  • 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.
  • Certified in SAS programming and knowledgeable in Base SAS, SAS/STAT, SAS Macro language ;
  • statistics (like regression and correlation analysis);
  • relevant regulatory guidelines and standards (e.g., FDA, ICH and EMEA);
  • prioritizing and managing multiple projects simultaneously; and
  • post marketing trials and medical affairs support.

 

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

 

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

 

Country: United States
Location: NJ-Whippany