Lead Statistical Programmer

Job not on LinkedIn

🔥 1 minute ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🖥 Software Engineer

👻 Ghost score 17%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Humaneva Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💊 Pharmaceuticals

🤝 B2B

💰 $50M Private Equity Round - Humaneva on 2024-09

Healthcare • Pharmaceuticals • B2B

Humaneva Group is a clinical-research-focused organization that integrates patient care, scientific innovation, and data-driven approaches to provide reliable clinical research data to the medical community. The Group comprises three interrelated companies: a research site network, a contract research organization (CRO), and a technology platform that together create a connected data stream between patients, investigators, research centers, and data standards. Humaneva emphasizes integration of clinical operations with technology and appears to support therapeutic areas such as oncology, according to its site navigation.

📋 Description

• Produce and coordinate SAS programs, outputs, and study reports for clinical trial programs • Independently perform quality control on statistical outputs to achieve First Time Right outputs • Function as study lead programmer and/or subject matter expert for complex studies • Lead project assignments and programming teams as point of contact with Project Management and sponsor teams • Maintain compliance with ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and company procedures • Participate in project kick-off meetings to understand scope, plans, timelines, and project-specific requirements • Develop and/or validate CDISC Data Standards specifications and programming for moderate-complex studies • Develop and/or validate programming for integration of databases from multiple studies and sources • Develop, validate, and document statistical programs for tables, figures, and listings • Create or review Define packages (Define.xml) and Reviewer Guides for CDISC Data Standards • Maintain, verify, and ensure quality and accuracy of assigned tasks • Complete client-specific and organization-specific training documentation on time • Forecast team workload and provide vision and clarity on project objectives, milestones, and upcoming projects • Assist with SAS programs, macros, templates, and utilities for data cleaning and reporting • Perform reconciliation of external data • Provide advanced technical expertise with minimal supervision for clinical data analysis and reporting • Mentor associates and support training for trainees and team members • Provide process-improvement inputs to increase efficiency and align processes with regulatory and industry requirements • Periodically evaluate team members and provide feedback • Support internal or external audit requirements and quality/process improvement initiatives • Perform other duties assigned by the Department Head or Immediate Supervisor

🎯 Requirements

• Any bachelor’s or master's degree, preferably in computer science, engineering, mathematics, statistics or life science • Minimum 8-10 years of relevant SAS programming experience for all clinical trial phases • Ability to independently perform SAS programming • Good working knowledge in all phases of clinical trials • Exposure in working in various therapeutic areas • Proficiency in clinical industry standards, CDISC Data standards, ICH-GCP Regulatory guidelines, medical terminology and clinical trial methodologies • Excellent verbal and written communication skills

🏖️ Benefits

• Employee position • Remote work arrangement