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.
Provides analytical insight on statistical methodology and advice to internal teams of accordingly.

Requirements

Bachelor’s Degree in Statistics or Biostatistics is required with at least 10+ years of relevant experience is required; OR Masters’s Degree in Statistics or Biostatistics is required with at least 8+ years of relevant experience is required.
5+ years of experience Biostatistician in the Biotech or Pharmaceutical industry is required.
Experience as a Lead Biostatistician on several concurrent projects required.
Experience with CDISC STDM/ADaM required.
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.
Excellent analytical skills with meticulous attention to detail.

Benefits

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
Exempt Employees are eligible for Unlimited PTO
Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

statistical analysissample size calculationsinterim analysesstatistical methodologystatistical analysis plansdata standardizationBayesian methodsadaptive trial designsSASclinical trial protocols

Soft Skills

problem-solvingcommunicationanalytical skillsattention to detailcollaboration