Senior Biostatistician

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

📋 Description

• Lead and assist in the design of phase I-III clinical trials, which includes sample size calculations, interim analyses, DMC activities, and randomization procedures.

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

• Create and prepare statistical analysis plans, statistical output shells, and specifications for analysis datasets.

• Guide and contribute to the creation, validation, traceability, reproducibility, and ongoing maintenance of analysis datasets and statistical outputs.

• Aid in the electronic submission of clinical trial data to regulatory authorities.

• Proactively address and resolve problems of statistical complexity.

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

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

• Offer analytical insights on statistical methodology and guidance to internal teams as needed.

• Stay updated on new clinical trial designs and statistical methodologies.

• As required, provide work direction, guidance, mentorship, influence, and support to junior staff.

• Train junior staff in advanced statistical methodologies.

• Develop, edit, and comply with Standard Operating Procedures (SOPs), process improvements, and standardization of templates.

• Carry out ad-hoc and cross-functional duties and/or projects as assigned to meet business needs and facilitate developmental opportunities.

⛳️ Requirements

• A Bachelor’s Degree in Statistics or Biostatistics is mandatory with a minimum of 7+ years of relevant experience; OR a Master’s Degree in Statistics or Biostatistics is required with at least 5+ years of relevant experience.

• At least 3+ years of experience as a Biostatistician in the Biotech or Pharmaceutical industry is essential.

• A working knowledge of clinical research, Good Clinical Practices (GCP), and regulatory requirements/guidelines is necessary.

• Proficiency in SAS; familiarity with sample size software such as nQuery or PASS is required.

• Experience serving as a Lead Biostatistician on multiple concurrent projects.

• Knowledge of CDISC STDM/ADaM is required.

• Exceptional English verbal and written communication skills; strong organizational and interpersonal skills are essential.

🏝️ 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