Associate Director, Biostatistics
Tandym Group ·careers.tandymgroup.com
Apply directA 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
Frequently asked questions
Who is hiring for the Associate Director, Biostatistics role?
Tandym Group is hiring for the Associate Director, Biostatistics position, a Shazamme client. Apply directly on the employer's career site.
Where is the Associate Director, Biostatistics job located?
The Associate Director, Biostatistics role with Tandym Group is based in Bedford, MA, US.
What does the Associate Director, Biostatistics role pay?
Tandym Group lists the Associate Director, Biostatistics role at USD 77–87 per hour.
Is the Associate Director, Biostatistics role full-time or contract?
This is a full time position at Tandym Group.
What experience level is the Associate Director, Biostatistics role?
The Associate Director, Biostatistics position is aimed at director-level candidates.
How do I apply for the Associate Director, Biostatistics role at Tandym Group?
Apply directly on Tandym Group's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.