Sr. Biostatistician - Remote

Contact: Neisha Camacho/Terra Parsons -
No 3rd party candidates

Primary Responsibilities:

• Provides support for all activities related to clinical development, including development of key study and program hypotheses, clinical development plans, study designs, regulatory meetings, submissions, and follow up.
• Applies innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design, and/or Bayesian approaches)
• Ensures accurate, statistically valid deliverables in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents
• Coordinates simultaneous achievement of major statistical deliverables and milestones for multiple clinical trials across the portfolio in collaboration with the clinical development team and other functions
• Leads and manages internal/external biostatistics resources supporting studies and programs.
• Collaborates with data management and statistical programming to provide timely and accurate biostatistics deliverables
• Monitors project progress and ensures proper resource allocation for successful project deliverables against goals and timelines
• Responsible for providing statistical input and leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies
• Collaborates with Data Management and Statistical Programming to build our internal capabilities and develops standard processes for CDISC compliant data sets (SDTM and ADaM), performing formal tables, listing & figure production and QC in preparation for submission readiness.

Experience:

• Candidates need a PhD in Biostatistics/Statistics or with a minimum of 10 years pharmaceutical industry experience or MS in Biostatistics/Statistics with a minimum of 15 years pharmaceutical industry experience.
• Extensive experience with IND/NDA activities and regulatory interactions, including filing, ISS and/or ISE experience.
• Experience with interim analysis design, conduct and manage/support data monitoring committee.
• Excellent SAS programming and analytical skills to develop programs to QC, using SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macros. Ability to do simulations in a programming language such as SAS or R.
• Knowledge of GCP/ICH guidelines for conducting clinical trials
• Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially the FDA
• Effective communicator: able to explain methodology and consequences of decisions in lay terms; able to understand requests for complex analyses, etc.
• Able to manage multiple projects and conflicting priorities, and to be flexible when priorities change
• Effective team player with willingness to go the extra distance to deliver results, meet/exceed deadlines, etc.

Nice to have: Machine Learning using R and/or Python; experience in an agile environment.