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.
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.