Reports to: Director, Clinical Operations
The Sr. Biostatistician is responsible for gathering, analyzing and interpreting clinical data in support of clinical programs and initiatives. S/he works closely across multiple groups, specifically Clinical Operations, Clinical Regulatory, and Medical Affairs, to provide key statistical information that supports strategic plans and enables successful execution of the same. The Sr. Biostatistician brings superb statistical and analytical skills to support the Fractyl DMR (Duodenal Mucosal Resurfacing) program, authoring Statistical Analysis Plans (SAPs), contributing to Clinical Protocols, Clinical Study Reports and statistical input for other relevant clinical documents (i.e. medical disclosures, medical information, safety summaries, Report of Prior Investigations (ROPI)). S/he provides statistical strategic input on regulatory submissions, and develops and executes innovative statistical strategies to support analysis of clinical and non-clinical data.
- Deliver statistical leadership for clinical development, clinical operations and clinical regulatory interactions.
- Support clinical study design, conduct, and analysis by bringing statistical expertise.
- Author and/or oversee production of statistical sections of protocols, statistical analysis plans, study reports, regulatory documents, and statistical sections of publications, etc.
- Conduct hands on exploratory statistical analysis and sample size calculations.
- Support data management activities with necessary statistical input (i.e. database design, CRF review, validation checks, review of Data Management Plans, protocol deviation review)
- Serve as the key statistical and analytical internal resource for medical disclosure planning and implementation.
- Plan, manage and oversee CRO statistical/programming activities, collaborating with external consultants as needed.
- Collaborate with cross-functional study teams and participate in related meetings/discussions; align timelines and deliver results.
- Bring a “can do” spirit to work and deliver on other responsibilities as assigned.
Education or Certification Requirements
- Masters in Statistics/Biostatistics or an equivalent degree
Professional Work Experience
- 6+ years’ experience in the device/pharma industry, PhD preferred
- Experience in sample size calculation, protocol concept/synopsis development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions
- Experience in type 2 diabetes and/or metabolic disorders and/or medical devices highly preferred
- Experience in the interactions with FDA, EMEA/CPMP and other regulatory agencies is preferred; successful submissions experience preferred (i.e. PMA)
- Able to identify issues, ask questions, and propose solutions
- Experience with vendor oversight and partnering with external vendors
- Experience with adaptive study designs, Bayesian experimental design, and real world evidence are preferred
- Experience with QC of datasets and critical outputs
Qualifications and Skills
- Successful track record of effective program and project management
- Current and thorough understanding of statistical principles, and ability to apply statistical strategy and principles to clinical protocols, analysis plans, study reports, and supporting documents
- Familiarity with US and EU regulatory guidance and guidelines, as well as general knowledge of industry best practices and standards; understanding & implementation of CDISC standards for regulatory submissions is preferred
- Strong statistical leadership in a cross-functional project environment, experience with medical devices preferred
- Effective writing and communication skills: able to author various statistical documents; able to help team understand complex statistical design, methodology and consequences of decisions, decision rule, analysis plan and statistical report
- Skilled in SAS programming, knowledge of R programming a plus
- Strong knowledge of ICH guidelines
Other Essentials and Key Success Factors:
- Successful track record of working in high-growth and dynamic organizations
- Strong organizational skills with the ability to effectively multi-task and prioritize
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
- Evidence of "hands-on" experience and expertise
- Ability to work autonomously under minimal direction
- Proven and successful track record as a team-player and collaborator in small working environments
- Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
- Highest levels of professionalism, confidence, personal values and ethical standards
The description and requirements outlined above are general; additional requirements may apply.