Principal Biostatistician

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the primary statistician for one or more clinical programs, managing all statistical elements from study design to regulatory submission.

• Oversee the design of all clinical trials, including calculations for sample size, interim analyses, DMC activities, and randomization processes.

• Spearhead the creation of clinical trial protocols and clinical study reports; author the statistical methodology section of these documents.

• Formulate and assess statistical analysis plans (SAPs), detailing methodology, sample size calculations, and strategies for interim analysis.

• Direct and assist in the development, validation, traceability, reproducibility, and upkeep of analysis datasets and statistical outputs.

• Manage the electronic submission of clinical trial data to regulatory bodies.

• Collaborate with clinical, regulatory, data management, and medical affairs teams to ensure statistical strategies align with program goals.

• Proactively address and resolve complex statistical challenges.

• Lead efforts in standardizing data (e.g., CRF and database design, edit checks, standard statistical programs, data presentations, data standards such as CDISC STDM/ADaM, and e-submissions).

• Effectively communicate intricate statistical concepts to non-statistical stakeholders, including senior leadership and external partners.

• Actively engage as a vital member of clinical study teams.

• Provide analytical insights on statistical methodologies and offer guidance to internal teams as needed.

⛳️ Requirements

• A Bachelor’s Degree in Statistics or Biostatistics is mandatory, accompanied by a minimum of 10 years of relevant experience; OR a Master’s Degree in Statistics or Biostatistics is required with at least 8 years of relevant experience.

• A minimum of 5 years of experience as a Biostatistician in the Biotech or Pharmaceutical industry is essential.

• Proven experience as a Lead Biostatistician on multiple concurrent projects is required.

• Familiarity with CDISC STDM/ADaM is necessary.

• A solid understanding of clinical research, Good Clinical Practices (GCP), and regulatory requirements/guidelines is expected.

• Knowledge of adaptive trial designs, Bayesian methods, or complex innovative designs is advantageous.

• Proficient in SAS; knowledge of sample size software such as nQuery or PASS is beneficial.

• Exceptional analytical skills with a keen attention to detail are crucial.

• Strong English verbal and written communication skills; excellent organizational and interpersonal abilities are required.

🏝️ Benefits

• Options for Medical, Dental, and Vision Plans

• Health and Financial Wellness Programs

• Employer Assistance Program (EAP)

• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability

• Flexible Spending Accounts for Healthcare and Dependent Care

• 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

• Exempt Employees are entitled to Unlimited PTO

• Non-Exempt Employees are granted 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days, and 1 Cultural Day