Associate Director, Biostatistics
$193,500–$250,500 year
RemoteUnited States or Woburn, Ontario, Canada
Job Summary
Provide statistical support for clinical development plans and serve as biostatistics lead for assigned studies, publications, and conference presentations. Develop statistical analysis plans, tables, listings, and figures while monitoring database activities and lock processes. Guide internal biometrics team and CRO project activities, including timelines and deliverables, and participate in pre-IND and NDA/BLA submissions. Assist in writing clinical study reports and validate data derivations using SAS. Ensure study designs are scientifically sound and regulatory requirements are met. This role may be based in Woburn, MA, or remote, requiring 15-25% travel every 4-6 weeks for remote candidates.
Required Qualifications
- PhD or MS in Biostatistics or Statistics
- At least three (3) years' experience for PhD, or five (5) years' experience for MS as statistician in the pharmaceutical or biotechnology industry
- Knowledge of advanced study design and up-to-date biostatistical methodologies
- Good knowledge of statistical programming languages (including SAS)
- Knowledge of SDTM/ ADaM
- Must be based either in our Woburn office or be a remote role
- Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 15-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require
Desired Qualifications
- Oncology (especially solid tumor) clinical trial experience
- Experience of NDA/BLA eCTDs or other global regulatory submissions
- Experience as an independent statistician with responsibility for multiple studies or projects
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