A pharmaceutical company in Massachusetts is actively seeking a new Associate Director, Biostatistics to join their growing team, contributing to study-level tasks and ensuring statistical integrity in clinical trials.

Responsibilities:
- Contributing to study-level tasks, including study design and sample size determination
- Authoring and reviewing statistical sections in protocols, SAPs, and DMC charters
- Creating and reviewing study randomization files
- Developing TFL shell and specifications
- Reviewing CRFs and other study documentation
- Collaborating within biometrics and cross-functional teams
- Ensuring the statistical integrity of deliverables
- Conducting analyses and proposing new statistical methodologies
- Contributing to developing standards and research in statistical methodologies
- Authoring/reviewing regulatory documents or scientific publications
- Performing other duties, as needed
Qualifications:
- PhD in Statistics or Biostatistics with a minimum of 5 years of experience, or a Master’s with 8 years
- Experienced in Clinical Trials in the Pharmaceutical industry
- Experienced in NDA/BLA/MAA activities and Regulatory interactions
- Leadership experience in Study-level tasks and strategy discussions
- Familiar with ICH guidelines and regulatory guidance
- Strong understanding of Mathematical and Statistical principles
- Familiar with SAS and R, and preferably CDISC standards
- Detail-oriented with strong organizational and problem-solving skills
Desired Qualifications:
- Advanced Degree in Statistics or Biostatistics
- Experience with Regulatory documents
- Strong proficiency in SAS and R
