Sr. Manager/ AD Biostatistics
- Biostatistics | FDA Experience | Oncology
- Northbrook, Illinois
- $140,000 - $185,000 +complete benefits package
A Pharmaceutical company is looking to hire a Sr Manager/AD Biostatistics acts as an entirely independent global statistical lead, representing Data Science in Core Teams (CMT or Development Core Team). May be accountable for one or for multiple global or local drug developments. Oversees large and/or complex assignments, cooperates with regulatory groups (Payers, HTAs, FDA, PMDA, EMA, etc.) and crucial opinion leaders, supervises other statisticians providing assistance to the schemes and is responsible for the statistical soundness of ALL statistical contribution and deliverables for the allocated ventures.
The Sr Manager/AD Biostatistics will have responsibilities that include:
- Provides strategic statistical input to project teams and is a major contributor to project/product level strategy
- Represents the company on statistical matters at meetings with regulatory authorities, key opinion supervisors and similar experts/bodies
- Contributes to project groups for clinical development platforms and/or lifecycle management of promoted products
- Presents finest in class data science backing to the company's drug development programs. Guarantees excellence and consistency of key data science deliverables throughout studies. Ensures innovation of, preservation and adherence to indication specific standards with regard to essential variables, definitions, statistical approaches, data structures and presentation of results.
- Executes vendor oversight for assigned programs: Guarantees CRO is supplied with details, timelines and the company's requirements and requests and kept up to date in case of changes. Supervises timelines, progress and specific issues, and takes action if necessary. Guarantees review of the outputs created by the CRO.
The ideal candidate will have the following skill set:
- M.S. or Ph.D. in statistics or equivalent degree/experience
- 7+ years in applying statistical methods in biomedical research, extensive pharmaceutical or CRO experience required or demonstrated ability to provide statistical direction in these areas
- Experience in working on clinical project teams. Good understanding of entire drug development process - ability to see the "big picture".
- Experience as the independent lead statistician in regulatory interactions preferred
- Experience with cross functional process improvement or innovation initiatives
- Experience with FDA regulatory submissions
- Familiarity with CDISC relating to FDA/EMA guidelines
- Very good oral, written, and presentation communication skills. Able to clearly communicate statistical issues and methods to both statisticians and non-statisticians.
- Oncology experience is strongly preferred
