Biomea Fusion

The Associate Director of Biostatistics is responsible for leading multiple clinical studies, provide statistical support on study design and all aspects of study conduct, including but not limited to author/review statistics section in the protocol, sample size determination; author/review statistical analysis plan and mock TFL, review study randomization files, ADaM specs, CRF design, DMC charter, analyze and interpret the clinical study results, and ensure statistical integrity.

Essential Responsibilities:

• Represents Biostatistics function at cross-functional meetings; collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting.
• Validate the results of key statistical deliverables, including topline TFL, perform ad hoc and exploratory statistical analyses
  Oversight of vendors to ensure timeliness and quality of analysis and statistical outputs
• Conduct independent statistical modeling and simulation or in collaboration with other team members to assist drug development strategy
  May perform submission related activities, represent department in meetings with regulatory agencies
• Support publications effort including manuscripts, conference presentations and posters
• Develops department processes and standards and trains junior department personnel as necessary in order to achieve department objectives
• Conduct ad hoc genomic analyses supporting Research and Development (RNA-Seq, etc.)

 Education and Experience Requirements:

• A PhD in statistics, biostatistics or related field with minimum of 6 years clinical trial experience in the pharmaceutical or Biotech Companies, or MS degree with minimum of 8 years of experience
• Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including survival analysis, Bayesian method, missing data imputation, multiplicity adjustment
• Proficiency with statistical programming in SAS and/or R
• Knowledgeable in CDISC standard including SDTM, ADaM
• Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance
• Highly proficient using Microsoft Office Suites. Knowledge of MS Teams is a plus.
• Collaborative, team-oriented mindset with strong verbal and written communication skills.
• Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills.