Senior Manager, Statistical Programming

🕒 Outubro 23

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

👻 Score fantasma 10%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 19 dias.
• As vagas desta empresa costumam ser preenchidas em 62 dias.
• Sem salário divulgado.

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EDETEK Inc.

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2009

💊 Farmacêutico

🧬 Biotecnologia

☁️ SaaS

Pharmaceuticals • Biotechnology • SaaS

A EDETEK Inc. é uma empresa de informática de desenvolvimento clínico que fornece um ecossistema de nuvem nativo para I&D e uma plataforma eClinical integrada para apoiar ensaios clínicos e submissões regulatórias. Seu portfólio de produtos inclui ferramentas de orquestração e colaboração CONFORM™, uma suíte eClinical (CTMS, EDC, ePRO/eCOA, RTSM), hubs de integração de dados e metadados, um data lake clínico e ambientes prontos para computação estatística e submissão. A EDETEK também oferece serviços — bioestatística e programação, gestão de dados clínicos, desenvolvimento de estudos clínicos, redação médica e operações eClinical — voltados para patrocinadores das indústrias farmacêutica, de biotecnologia e de dispositivos médicos. A empresa enfatiza interoperabilidade, qualidade de dados e capacidades habilitadas por IA para acelerar a execução de estudos e submissões regulatórias globalmente.

Descrição

• Program all tables, listings and graphs necessary for an assigned clinical study report (CSR). • Act as lead programmer for assigned projects. • Program customized data displays in accordance with the approved statistical analysis plan (SAP) and shell displays for clinical research studies. • Write code using Base SAS programs, SAS procedures, or standardized macros. • Analyze protocols, SAPs, and existing shells/templates to understand data structure and content. • Perform data checks to ensure integrity and correctness of data displays. • Prepare documentation for programs, datasets, variables, derived variables, and projects. • Create SAS datasets of clinical data from clinical databases. • Create status and efficacy datasets. • Create project-specific macros and formats. • Load client data from other platforms and software packages. • Prepare data for clients and external transfers/data imports. • Communicate with clients to set and manage project timelines and deliverables. • Assign projects to the team and solve problems or technical difficulties. • Train junior team members on industry regulations, standards, and internal tools. • Work with IT to set up and ensure a secure environment with proper access control on SAS servers. • Work with Quality Assurance on Standard Operation Procedures drafting/revision and testing and validation of CONFORM modules.

🎯 Requisitos

• Ability to communicate effectively in English, in both writing and verbal. • Ability to learn quickly and pay attention to details. • Ability to manage multiple tasks/projects, effectively prioritize and execute tasks, and make quality and on time deliveries. • Ability to work collaboratively, effectively, and productively in diverse organizational structures, and in interaction with dynamic clients. • Ability to work independently, takes ownership and strives for quality and efficiency. • Ability to work positively in a continually changing environment. • Solid/Advanced SAS skills and understanding of the concept of standardization in data, programming, and statistical reporting of trial results and its implication to drug development. • Master’s degree or above in Biostatistics, Computer Science, Mathematics, or a combination of education and relevant industry experience. • Strong SAS programming language and good knowledge/experiences of clinical trial and drug development. • At least 2 years of clinical SAS programming experience for the manager position. • Some travel (5%) may be required with a potential of travel occurring over weekends. • Cross-functional interactions

🏖️ Benefícios

• Choice of comprehensive Medical, Vision and Dental Insurance plans • Paid vacation time and sick days • Corporate holidays annually • Participation in the 401K Plan • Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc. • Health Advocate and Employee Assistance Program

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