Director, Biostatistics

Role Summary

In this role, you will lead statistical aspects of clinical development projects and ensure statistical strategies and methodologies align with clinical development objectives and regulatory expectations. This critical role requires strong statistical and cross-functional leadership to influence clinical development and decision-making to support company’s goals. You will work collaboratively with multiple functions, such as medical, clinical science, clinical operations, clinical pharmacology, translational medicine, pharmacovigilance, regulatory affairs, and data management to plan, execute and interpret statistical analyses to ensure analysis integrity and quality, in compliance with regulatory standards.

Your Role

• Lead and execute statistical strategies for one or more clinical studies, including contribution to study design, statistical analysis, study results interpretation, clinical study report, database lock, regulatorysubmissionsand publications
• Accountable for timeliness, quality, integrity and consistency of study and submission level statistical deliverables on assigned projects
• Provide statistical input for cross-functional activities, collaborate with other functions to make progress on projects, and provide insights and leadership to influence decision-making
• Lead or contribute to studyand regulatorydocuments such as study protocols, statistical analysis plans, mockup shells, endpoint assessment charters,Case Report Forms (CRFs),Investigational New Drug (IND) applications, and New Drug Applications (NDAs)
• Plan, perform andvalidatestatistical analyses of clinical trial data using SAS or Rin accordance withregulatory and internal standards
• Contribute to study design, including performing simulations to assess operating characteristics and optimize design parameters
• Apply advanced and innovative statistical methods to support business needs
• Design and execute exploratory data analyses to assess data trends,formand test hypotheses, and generate new insights from clinical trial data
• Manage and oversee statistical and programmingClinical Research Organizations (CROs)and vendors to ensure high-quality andtimelydeliverables
• Contribute to department processes,SOPsand initiatives
• Maintain awareness of industry standards, trends, and regulatory requirements
• Other duties and responsibilities as assigned

Qualifications

• Required:
  APhD in Statistics, Mathematics, or a related field with a minimum of eight years of industry experience in clinical trials, or Master’s Degree in a similar discipline with at least ten years of industry experience in clinical trials, including experience in oncology drug development from Phase 1/2 to Phase 3
• Demonstrated technical knowledge of statistical methodology and proven ability to appropriately apply it in trial design, analysis and result interpretation to support clinical development, including experience working with SDTM, ADaM, eSUB, and CDISC requirements
• Strong hands-on skills in statistical analyses, modeling and trial simulation, including proficiency in programming languages such as SAS and R, as well as experience with external control and biomarker analyses
• Experience with regulatory submissions including NDAs or BLAs
• Experience in overseeing CRO and consultants to deliver high quality outputs

Preferred

• Experience with data science and/or machine learning
• Experience with RWE, RWD, and/or Trial Simulation