Principal Biostatistician

Jobtailor; Cambridge (MA); On-site; USD 120,000 - 190,000; Full time

Job summary

Jobtailor in Cambridge, MA seeks a Biostatistician with a PhD or MS and extensive experience to oversee complex drug program statistics. The role involves leading study-level decisions and collaborating with diverse clinical and regulatory teams.

You will apply advanced statistical methods, drive innovative solutions, and communicate results effectively across stakeholders, ensuring alignment with trial designs and regulatory expectations.

Qualifications

• PhD in Biostatistics/Statistics or equivalent with 4 years relevant experience.
• MS in Biostatistics/Statistics with 6 years relevant experience.
• Strong understanding of statistical principles and clinical trial methodology.
• Ability to provide innovative and practicable technical solutions.
• Working knowledge of medical/biological terminology and trial designs.
• Proficiency in writing and presenting information effectively.
• Conversant with SAS programming and statistical software.
• Familiarity with regulatory guidelines for statistical analysis.
• Demonstrated leadership and communication skills.

Responsibilities

• Manage a moderate or large volume of complex tasks with minimal supervision across one or more drug programs
• Proactively assess and adapt solutions for the Biometrics department, resolving technical issues
• Make decisions at the study level across various studies, leading and prioritizing tasks globally
• Collaborate closely with clinical research, regulatory affairs, CROs, Commercial, Worldwide Medical, KOLs, and other disciplines
• Monitor needs and determine resources in consultation with line managers
• Participate in organization-wide initiatives such as quality and standardization efforts

Skills

Biostatistics

Statistical methods

SAS programming

Clinical trial design

Leadership

Communication skills

Education

PhD in Biostatistics/Statistics

MS in Biostatistics/Statistics

Tools

SAS

R

Job description

Responsibilities

• Manage a moderate or large volume of complex tasks with minimal supervision across one or more drug programs
• Proactively assess and adapt solutions for the Biometrics department, resolving technical issues
• Make decisions at the study level across various studies, leading and prioritizing tasks globally
• Collaborate closely with clinical research, regulatory affairs, CROs, Commercial, Worldwide Medical, KOLs, and other disciplines
• Monitor needs and determine resources in consultation with line managers
• Participate in organization-wide initiatives such as quality and standardization efforts

Requirements

• PhD in Biostatistics/Statistics or equivalent with 4 years relevant experience
• MS in Biostatistics/Statistics with 6 years relevant experience
• Thorough understanding of statistical principles and clinical trial methodology
• Ability to provide innovative and practicable technical solutions
• Working knowledge of medical/biological terminology and clinical trial designs
• Proficiency in writing and presenting information effectively
• Conversant with SAS programming and detailed knowledge of statistical software
• Working knowledge of regulatory guidelines and needs for statistical analysis
• Demonstrated leadership and communication skills