Principal Statistical Programmer

🕒 il y a 1 mois

🏄 California, Illinois, +2 états de plus – Distant

🏄 California – Remote 🌽 Illinois – Remote 🗽 New York – Remote 🍂 Massachusetts – Remote

💵 $162 000 - $180 000 / an

⏰ Temps Plein

🔴 Expert

🖥 Ingénieur Logiciel

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ImmunityBio, Inc.

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501 - 1000 employés

🧬 Biotechnologie

⚕️ Assurance santé

💊 Pharmaceutique

Biotechnology • Healthcare Insurance • Pharmaceuticals

ImmunityBio, Inc. est une entreprise de biotechnologie axée sur le développement d'immunothérapies innovantes pour renforcer la capacité du système immunitaire à combattre le cancer et les maladies infectieuses. En exploitant la puissance de la réponse immunitaire de l'organisme, ImmunityBio vise à fournir des traitements révolutionnaires qui peuvent améliorer les résultats et la longévité des patients atteints de maladies difficiles.

Description

• Lead all aspects of the statistical programming activities including efficient programming techniques. • Lead all aspects of creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs. • Contribute to and review of statistical analysis plans and analysis datasets specifications and prepare the electronic submission of clinical trial data to regulatory authorities. • Create specifications, develop, and validate of CDISC SDTM and regulatory deliverables (Define.xml, SDTM aCRF, cSDRG). • 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). • Communicate with regulatory agencies regarding electronic data submission requirements. • Participate effectively as an ad-hoc member on clinical development and regulatory submission teams. • Provide effective solutions for complex statistical programming tasks. • Create and manage projects and study electronic subdirectories ensuring consistency in structure. • Contribute to the design, creation, and validation of global programming macros that streamline programming activities and increase efficiency. • Anticipate statistical programming resource needs and work with management to ensure adequate long-term resource allocation within a project • Conduct resource planning and budgeting for statistical programming activities of a project. • Participate in development of new processes or revision of existing processes. • Keep current with new statistical programming techniques and technical advancements. • As necessary, provide work direction, guidance, mentoring, influence and support to junior staff. • Train junior staff in more complex statistical programming techniques. • 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 assigned to support business needs and provide developmental opportunities.

🎯 Exigences

• Bachelor’s Degree in Statistics/Biostatistics, Computer Science, or Mathematics with at least 10+ years of relevant experience is required, OR Master’s Degree in Statistics/Biostatistics, Computer Science, or Mathematics with at least 8+ years of relevant experience is required. • 5+ years of experience as a statistical programmer in the pharmaceutical industry is preferred. • Expert in CDISC STDM guidelines • Expert in CDISC SDTM regulatory deliverables (Define.xml, SDTM aCRF, cSDRG) • Experience as a lead statistical programmer on several concurrent projects • Working knowledge of the clinical research, Good Clinical Practices, and regulatory requirements/guidelines. • Technically strong with regard to statistical programming processes and activities. • Highly proficient in SAS. • Excellent English verbal and written communication skills; good organizational and interpersonal skills.

🏖️ Avantages

• 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