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Jobs · Analyst · New York

Principal Statistical Programmer - Dunkirk / Buffalo NY

ImmunityBio, Inc. · Dunkirk, NY · 1 mo ago
On-siteAnalyst$162k/yrFull-time

ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products designed to strengthen each patient’s natural immune system, enabling it to outsmart disease and eliminate cancerous or infected cells. Our vision is to conquer cancer by reprogramming the immune system to treat the host rather than just the disease.

About the role

A Principal Statistical Programmer is an expert in management, technical oversight, and quality of statistical programming activities related to the analyses of clinical trial data, ensuring timelines and company strategic objectives are met. As a CDISC SDTM specialist, you will provide industry-leading CDISC expertise and programming leadership, contribute to process improvements, and mentor junior staff.

Responsibilities

  • Lead all aspects of statistical programming activities, including efficient programming techniques.
  • Oversee creation, validation, traceability, reproducibility, and maintenance of analysis datasets and statistical outputs.
  • Contribute to and review statistical analysis plans, analysis dataset specifications, and prepare electronic submissions of clinical trial data to regulatory authorities.
  • Create specifications, develop, and validate CDISC SDTM and regulatory deliverables (Define.xml, SDTM aCRF, cSDRG).
  • Provide input or lead data standardization efforts (e.g., CRF/database design, edit checks, standard statistical programs, CDISC STDM/ADaM, e-submissions).
  • Communicate with regulatory agencies regarding electronic data submission requirements.
  • Participate as an ad-hoc member on clinical development and regulatory submission teams.
  • Provide effective solutions for complex statistical programming tasks.
  • Create and manage project and study electronic subdirectories, ensuring consistency in structure.
  • Contribute to the design, creation, and validation of global programming macros to streamline activities and increase efficiency.
  • Anticipate statistical programming resource needs and work with management to ensure adequate long-term resource allocation.
  • Conduct resource planning and budgeting for statistical programming activities.
  • Participate in the development of new processes or revision of existing ones.
  • Stay current with new statistical programming techniques and technical advancements.
  • Provide work direction, guidance, mentoring, and support to junior staff; train them in complex techniques.
  • Create, edit, and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
  • Perform ad-hoc and cross-functional duties/projects to support business needs and provide developmental opportunities.

Requirements

  • Bachelor’s Degree in Statistics/Biostatistics, Computer Science, Mathematics, or related field with at least 10+ years of relevant experience, OR
  • Master’s Degree in Statistics/Biostatistics, Computer Science, Mathematics, or related field with at least 8+ years of relevant experience.
  • 5+ years of experience as a statistical programmer in the pharmaceutical industry is preferred.
  • Expertise in CDISC STDM guidelines and regulatory deliverables (Define.xml, SDTM aCRF, cSDRG).
  • Experience as a lead statistical programmer on several concurrent projects.

Skills

  • Working knowledge of clinical research, Good Clinical Practices, and regulatory requirements/guidelines.
  • Technically strong in statistical programming processes and activities.
  • Highly proficient in SAS.
  • Excellent English verbal and written communication skills; strong 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) including 11 Holidays
  • Exempt Employees: Unlimited PTO
  • Non-Exempt Employees: 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days, and 1 Cultural Day

Pay

The annual base pay range for this position is:

  • National Market (all markets unless identified as Premium): $162,000 (entry-level qualifications) to $180,000 (highly experienced) annually
  • Premium Market (Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston): $171,000 (entry-level qualifications) to $190,000 (highly experienced) annually

This position is eligible for a discretionary bonus and equity award. Relocation assistance is available for eligible candidates.

Schedule

  • Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.
  • This is an on-site role based at ImmunityBio's Dunkirk, New York campus.

About Our Dunkirk Campus

Our Dunkirk campus is undergoing significant expansion as ImmunityBio builds one of the nation's premier commercial cell therapy manufacturing operations. Located along the shores of Lake Erie, Dunkirk offers an outstanding quality of life, affordable living, and convenient access to Buffalo, Niagara Falls, Toronto, and year-round outdoor recreation.

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