Principal Biostatistician - Remote

Roles and Responsibilities

• Lead complex projects, programs and submissions, manage client meetings, CRMs, collaborate well with regulatory, PMs and sponsors.
• Can develop SAPs and iSAPs text and shells with no supervision.
• Produce and present external company presentations providing industry visibility for the organization; continually suggesting solutions to solve issues in tune with organizational direction.
• Can review or develop ADAM specifications; can work with programmers and junior statisticians to resolve comments.
• High technical level, Subject Matter Expert in biostatistics; willing to guide others in a variety of biostatistical techniques.
• Has the ability to apply drug development knowledge during production of complex statistical analyses.
• Review or create the statistical section(s) of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study.
• Prepare and review statistical methods and results sections for the CSR independently in collaboration with in-house medical writers.
• Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation/management.
• Perform sample size calculations for a variety of scenarios and study designs. Can provide statistical consulting support to sponsors regarding study design and sample size calculations.
• Ability to create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams.
• Understand the various tools that we work with and able to use them correctly (for SCM: checks in/out; use of external SharePoint).
• Provide support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
• Is familiar with and stays current with the latest industry practices and updated regulatory guidelines.
• Write blogs and/or white papers for posting on the company website.

• Masters in Biostatistics, Statistics discipline or related field, or related experience;
  PhD preferred.
• Minimum of 7 years’ experience in Biostatistics, Statistics or similar field required.
• Submission experience (ISS/ISE).
• Has high level knowledge of drug development as it pertains to biostatistics.
• Expert knowledge of scientific principles and concepts.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Good organizational skills.
• High proficiency with MS Office applications.
• Hands‑on experience with clinical trial and pharmaceutical development preferred.
• Excellent problem‑solving skills.
• Familiarity with current ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Good understanding of CROs and scientific & clinical data/terminology, and the drug development process.