Lead Biostatistician, REMOTE

  • Chatham, NJ
  • Full-time

Company Description

Instat Services provides comprehensive statistical services for all phases of clinical drug development. We are a small group of experts who focus on the client relationship and help our clients achieve big successes on their projects across many therapeutic areas such as Oncology, Neuroscience, Cardiovascular and others. We’re 100% remote, so you can work from the comfort of your home office. We don’t bother with office politics, and we value a healthy work-life balance. Most of all, we love what we do!

Job Description

Instat is looking for a Lead Biostatistician who will manage projects that include study design, protocol development, sample size justification, data conversion, and planned and exploratory analyses using SAS. Most of our projects are Phase I - IV clinical trials. Excellent organizational and communication skills are required to coordinate project activities, promote the understanding and communication of trial data, prepare statistical analysis plans (SAPs), design and produce statistical summary tables and perform database integration for analyses.

Primary Responsibilities

  • Function as a Lead Biostatistician for projects assigned, including coordinating all project team activities and ensuring client expectations are met.
  • Work with the Account Lead to monitor project budgets, time spent on the project by the team, and plan appropriate resources.
  • Function as primary contact for the client, and support clients on project related statistical issues.
  • Develop scientifically sound study designs and contribute to study design sections of clinical trial protocols.
  • Develop statistical analysis plans (SAP) to meet objectives defined in protocol.
  • Provide consultation to clinical project team on any statistical issues related to the trial conduct.
  • Lead the analysis of clinical trial data, oversee all statistical programming on the project and address all issues.
  • Program and/or validate statistical summary tables and reports using SAS for planned and exploratory post-hoc and meta-analyses.
  • Perform post-hoc analyses and relevant exploratory analyses of clinical trial data for conference presentation and manuscript submission.

Qualifications

  • PhD in Biostatistics with 8+ years of experience or Master’s of Science in Biostatistics with 10+ years of experience
  • Minimum of 8 years of experience as biostatistician in clinical research
  • Good leadership, organizational, and time management skills, with the ability to multi-task.
  • Familiarity with clinical trial design and analysis activities and strong knowledge of regulatory guidelines.
  • Excellent analytical skills, with the ability to process and analyze scientific and medical data using SAS.
  • Ability to identify and solve complex technical problems.
  • Capability to communicate technical concepts clearly and concisely to non-statistical colleagues.
  • Effective in working collaboratively across cross-functional teams.

Additional Information

  • Home-based position that may include onsite assignments with clients.
  • All your information will be kept confidential according to EEO guidelines.