Primary Responsibilities:

Company is seeking a candidate with both clinical and theoretical expertise to join our team. Experience in early-phase clinical studies is essential. Given the limited data available for this project, we are looking for individuals who possess a strong inquisitive nature and are comfortable navigating complex research designs.

This role will focus on rare diseases, with neuro experience being a valuable bonus. While a PhD is preferred, candidates with a Master's degree and substantial experience are also encouraged to apply. Strong simulation experience is a must, along with excellent communication skills.

The successful candidate will serve as the primary point of contact for program studies, managing study oversight and collaborating closely with CROs. They will be expected to lead efforts in simulation, adaptive design, and forecasting sample sizes, with experience in regulatory submissions also highly valuable. The ability to perform simulations and hypothesis testing is critical, and machine learning experience would be an added advantage. Effective communication is key, as this person will be working across teams and presenting complex analyses in clear, actionable terms.

Job Description:

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:

• PhD in Biostatistics/Statistics or equivalent with a minimum of 10 years relevant work experience or MS in Biostatistics/Statistics or equivalent with a minimum of 15 years relevant 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.