This job is closed
Applications are no longer available for this announcement. Explore current related opportunities below.
Job description
We are looking for an experienced Senior Biostatistician to join our team and play a pivotal role in the design, analysis, and reporting of clinical trials. You will work closely with clinical, regulatory, and data management teams to ensure the statistical integrity of our studies from inception through to submission. The profile will work in close contact with and report to the Chief Medical Officer. The position is to be considered office-based (New York City)
Responsibilities
Lead the statistical design of Phase I–IV clinical trials, including sample size calculations, randomisation schemes, and adaptive design strategies
Author and review Statistical Analysis Plans (SAPs), protocols, and clinical study reports in line with ICH E9 and E9(R1) guidelines
Perform and oversee statistical analyses using SAS, R, or equivalent software, ensuring accuracy, reproducibility, and regulatory compliance
Prepare and review tables, listings, and figures (TLFs) for regulatory submissions (NDA, MAA, IND)
Provide statistical input to regulatory authority interactions, including responses to queries from the FDA, EMA, and other agencies
Collaborate with Data Management and Regulatory Affairs on CRF design, data validation, and CDISC-compliant datasets (SDTM, ADaM)
Mentor and guide junior statisticians, fostering a culture of scientific rigour and continuous learning
Contribute to process improvement initiatives and the development of internal statistical standards
Qualifications & Personal Skills
MSc or PhD in Statistics, Biostatistics, or a closely related discipline
Minimum 5 years of experience in clinical trial statistics within a pharmaceutical, biotech, or CRO environment
Strong proficiency in SAS (Base, STAT, MACRO) and/or R
Solid working knowledge of ICH guidelines (E9, E9(R1), E6 GCP) and CDISC standards
Proven experience contributing to regulatory submissions
Preferred Qualifications
Experience with adaptive or Bayesian trial designs
Familiarity with estimands framework (ICH E9(R1))
Exposure to therapeutic areas such as oncology, cardiovascular, or rare diseases
Experience in mixed or medical device / combination product trials is a plus
#J-18808-Ljbffr
Worksite address
minneapolis, MN, 55400, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.