Senior Biostatistician

Role Description

The Senior Biostatistician will be the subject matter expert in the design, management, technical oversight, and quality of statistical analyses and reporting of clinical trial data ensuring timelines and company strategic objectives are met.

Essential Functions

• 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 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.

Qualifications

• Bachelors’ Degree in Statistics or Biostatistics is required with at least 7+ years of relevant experience; OR
• Masters’s Degree in Statistics or Biostatistics is required with at least 5+ years of relevant experience.
• 3+ years of experience as a Biostatistician in the Biotech or Pharmaceutical industry is required.

Requirements

• 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
• We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.