Job Description
Job Description
Job Description
Contact: Neisha Camacho/Terra Parsons -
No 3rd party agencies
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
- Serves as a strategic partner with clinical team to aid in quantitative clinical decisions
Experience:
- PhD in Biostatistics/Statistics or equivalent with a minimum of 5 years relevant work experience or MS in Biostatistics/Statistics or equivalent with a minimum of 10 years relevant experience
- Candidates must have strong simulation experience using R with some SAS capability as well
- 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.
- 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.
- Excellent written and verbal communication
Nice to have: Machine Learning using R and/or Python; experience in an agile environment
Job Tags
Remote job, Work experience placement, Interim role, Worldwide, Flexible hours,