Senior Manager, Statistical Programming

Job not on LinkedIn

🔥 1 minute ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 10%

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EDETEK Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2009

💊 Pharmaceuticals

🧬 Biotechnology

☁️ SaaS

Pharmaceuticals • Biotechnology • SaaS

EDETEK Inc. is a clinical development informatics company that provides a cloud-native R&D Cloud ecosystem and an integrated eClinical platform to support clinical trials and regulatory submissions. Its product portfolio includes CONFORM™ orchestration and collaboration tools, an eClinical Suite (CTMS, EDC, ePRO/eCOA, RTSM), data integration and metadata hubs, a clinical data lake, and statistical computing and submission-ready environments. EDETEK also offers services — biostatistics and programming, clinical data management, clinical study development, medical writing, and eClinical operations — targeting pharmaceutical, biotechnology, and medical device sponsors. The company emphasizes interoperability, data quality, and AI-enabled capabilities to accelerate study execution and regulatory submissions globally.

📋 Description

• 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.

🎯 Requirements

• 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

🏖️ Benefits

• 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