Director, Biostatistics

Role Summary:

The Director, Biostatistics will provide leadership and guidance for assigned clinical studies within a clinical development program(s). This person will be responsible for statistical activities including: designing innovative clinical trials, authoring statistical sections of protocols, preparing statistical analysis plans, ensuring quality in implementation of statistical analysis, interpreting and communicating the results of statistical analysis of clinical trial data in support of regulatory submissions as well as manuscripts. The ideal candidate must be a good communicator, exhibit high-energy, self-motivation, and forward-thinking. Experience working in rare disease is desirable.

This role is based in Waltham, MA with hybrid work flexibility.

Primary Responsibilities Include:

• Serve as a biostatistics lead for assigned clinical studies, (or compound-level activities as required)
• Effectively interact with members in other functions including medical, regulatory, safety, clinical operations and translational medicine for planning to ensure optimized delivery of clinical study activities
• Work collaboratively with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverables

• Contribute to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles
• Design and specify stratification /randomization schema; review and approve test randomization lists
• Collaborate with Data Management, Clinical Development and Clinical Operations on design and review of eCRFs, and ensure data collection meet the requirements of statistical analyses
• Author or contribute to the development of statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE) as necessary,
• Provide guidance to statistical programmers on SDTM/ADaM and draft (or oversee) the development of shells for tables, figures and listings (TFLs)
• Provide statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents
• Provide statistical review of statistical deliverables (e.g ADaM datasets, TFLs)
• Contributes to clinical study reports and other regulatory documents as required e.g. DSURs, Briefing Documents, etc.
• Perform ad hoc and exploratory statistical analyses as needed
• Assist in assigned statistical activities in support of IND/NDA/MAA or other regulatory submissions
• Assist in addressing statistical questions/comments from FDA and other regulatory agencies, and review and address comments by IRB/ECs
• Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations
• Identify and implement emerging new ways of doing clinical development and new methodologies
• Contribute to standardization and process improvement efforts for Biostatistics function and contribute to cross-functional process improvement efforts

Education and Skills Requirements:

• Ph.D. (or Masters) in statistics or Biostatistics or equivalent with at least 10 years of experience in the pharmaceutical or biotech industry desired
• Interest in and basic understanding of biology and biological process including ASO and siRNA
• Demonstrated ability and experience in the design, analysis and reporting of clinical trials Experience in NDAs, MAAs or other regulatory submissions desirable
• In-depth knowledge of statistical methods for clinical trials, including both frequentist and Bayesian approaches
• Knowledge of FDA, EMA and ICH regulations and guidelines
• Proficient in statistical programming (SAS is required and R is a plus)
• Experience with trial design software (e.g., EAST)
• Ability to concurrently lead statistical efforts for multiple studies
• Understanding of data standards, including SDTM and ADaM
• Adept at overseeing statistical services provided by CRO’s and/or contractors
• Ability to work independently and act with initiative to address issues
• Ability to effectively communicate statistical concepts in a clear and concise manner both written and verbally.