Principal Biostatistician

About the role

The Principal Biostatistician will oversee all statistical aspects of clinical trials, from study design to regulatory submission. They will lead the design of clinical trials, including sample size calculations, interim analyses, Data Monitoring Committee (DMC) activities, and randomization procedures. They will also guide the creation and review of statistical analysis plans (SAPs).

Responsibilities

• Serve as the lead statistician for one or more clinical programs, overseeing all statistical aspects from study design through regulatory submission.
• Lead the design of all clinical trials including sample size calculations, interim analyses, DMC activities, and randomization procedures.
• Lead the development of clinical trial protocols and clinical study reports; write statistical methodology section of these documents.
• Develop and review statistical analysis plans (SAPs), including methodology, sample size calculations, and interim analysis strategies.
• Guide and contribute to the creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs.
• Lead the electronic submission of clinical trial data to regulatory authorities.
• Partner with clinical, regulatory, data management, and medical affairs teams to align statistical approaches with program objectives.
• Proactively solve problems of statistical complexity.
• Lead data standardization efforts (e.g., CRF and database design, edit checks, standard statistical programs, data presentations, data standards such as CDISC STDM/ADaM, and e-submissions).
• Communicate complex statistical concepts clearly to non-statistical stakeholders, including senior leadership and external collaborators.
• Participate effectively as a key member on clinical study teams.
• Provide analytical insight on statistical methodology and advice to internal teams of accordingly.

Requirements

• Working knowledge of clinical research, Good Clinical Practices (GCP), and regulatory requirements/guidelines.
• Experience with CDISC STDM/ADaM.
• Knowledge of adaptive trial designs, Bayesian methods, or complex innovative designs.
• Proficient in SAS; familiar with sample size software such as nQuery or PASS.
• Ability to align statistical approaches with broader business and regulatory goals.
• Ability to influence decisions and mentor others.
• Excellent analytical skills with meticulous attention to detail.
• Excellent English verbal and written communication skills; good organizational and interpersonal skills.

Qualifications

• Bachelor’s Degree in Statistics or Biostatistics with at least 10+ years of relevant experience.
• Masters’s Degree in Statistics or Biostatistics with at least 8+ years of relevant experience.
• 5+ years of experience as a Biostatistician in the Biotech or Pharmaceutical industry.
• Experience as a Lead Biostatistician on several concurrent projects.
• Experience with CDISC STDM/ADaM.

Skills

• Working knowledge of clinical research, Good Clinical Practices (GCP), and regulatory requirements/guidelines.
• Knowledge of adaptive trial designs, Bayesian methods, or complex innovative designs.
• Proficient in SAS; familiar with sample size software such as nQuery or PASS.
• Ability to align statistical approaches with broader business and regulatory goals.
• Ability to influence decisions and mentor others.
• Excellent analytical skills with meticulous attention to detail.
• Excellent English verbal and written communication skills; good organizational and interpersonal skills.

Benefits

Our competitive total rewards benefits package includes:

• Medical, Dental and Vision Plan Options
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• Healthcare and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
• Paid Time Off (PTO) includes: 11 Holidays

Pay

The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.

• National Market (all markets unless identified as Premium): $175,000 (entry-level qualifications) to $195,000 (highly experienced) annually
• Premium Market (Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston): $184,500 (entry-level qualifications) to $205,000 (highly experienced) annually

Schedule

This position works onsite or remotely depending on the candidate’s geographic location. Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.