Lead and contribute to the design of phase I-III clinical trials including sample size calculations, interim analyses, DMC activities, and randomization procedures.
Lead and contribute to the development of clinical trial protocols and clinical study reports; write statistical methodology section of these documents.
Develop and prepare statistical analysis plans, statistical output shells, and analysis dataset specifications.
Guide and contribute to the creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs.
Contribute to the electronic submission of clinical trial data to regulatory authorities.
Proactively solve problems of statistical complexity.
Provide input or 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).
Participate effectively as a key member on clinical study teams.
Provides analytical insight on statistical methodology and advice to internal teams of accordingly.
Keep current with new clinical trial designs and statistical methodology.
As necessary, provide work direction, guidance, mentoring, influence and support to junior staff.
Train junior staff in more complex statistical methodology.
Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Requirements

Bachelors’ Degree in Statistics or Biostatistics is required with at least 7+ years of relevant experience is required; OR Masters’s Degree in Statistics or Biostatistics is required with at least 5+ years of relevant experience is required.
3+ years of experience Biostatistician in the Biotech or Pharmaceutical industry is required.
Working knowledge of clinical research, Good Clinical Practices (GcP), and regulatory requirements/guidelines.
Proficient in SAS; familiar with sample size software such as nQuery or PASS.
Experience as a Lead Biostatistician on several concurrent projects.
CDISC STDM/ADaM experience.
Excellent English verbal and written communication skills; good organizational and interpersonal skills.

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 methodologydata standardizationstatistical output shellsanalysis dataset specificationsclinical trial protocolsclinical study reportsGood Clinical Practices

Soft Skills

analytical insightproblem solvingmentoringguidancecommunicationorganizational skillsinterpersonal skillsleadershipteam collaborationprocess improvement