Senior Statistician

Provide statistical expertise in clinical trials and collaborate with Clinical Research and Medical Writing groups on clinical trial protocols, case report forms, statistical analysis plans and other study related documents.
Provide guidance to study statisticians in SAP writing, statistical analysis, and derived datasets; ensure the accuracy and quality of statistical output.
Generate and interpret statistical reports, tables, figures, and statistical sections of clinical study reports.
Manage study resources and timelines, ensuring quality delivery of analysis results in a timely fashion.
Provide statistical expertise and advice for submission of marketing applications (NDA/BLA) to FDA, EMEA, or other worldwide regulatory agencies.
Maintain in-depth knowledge of FDA, EMEA, and ICH guidelines, as well as data standards such as CDISC, SDTM, and ADaM.
Collaborate with cross-functional teams, including data management and clinical operations, to deliver high-quality analyses.
Mentor and provide guidance to junior statisticians and analysts.

M.S. or Ph.D. in Statistics or Biostatistics.

5+ years (M.S.) or 3+ years (Ph.D.) of experience in clinical trials for regulatory submissions in pharmaceutical, biotech, or CRO environments.

Excellent analytical, communication, and writing skills.

Strong programming skills in SAS, S-Plus, or other statistical software.

Ability to lead and manage multiple projects effectively.