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:
Who you are
- 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.
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%.
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:
A little about us:
Why Bayer? Because we’re a pioneer in the fields of human, animal, and plant health. Because we invent solutions that will create a sustainable future for our planet. Because a career with Bayer means you can put your passion into practice and make an impact.