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.
- 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.