Senior Statistical Programmer

Yesterday

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $112k - $140k / year

⏰ Full Time

🟠 Senior

🖥 Software Engineer

🦅 H1B Visa Sponsor

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eClinical Solutions

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Biotechnology • Pharmaceuticals • Healthcare Insurance

eClinical Solutions is a clinical data management company that provides integrated data review and management solutions for the biotech and pharmaceutical industries. Their platform, elluminate, empowers organizations to modernize and automate their clinical data workflows, ensuring efficient data acquisition, management, and analysis. By leveraging advanced analytics and technology-driven approaches, eClinical Solutions helps streamline trial operations and improve productivity, enabling better decision-making in clinical research.

201 - 500 employees

Founded 2012

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Private Equity Round on 2020-01

📋 Description

• Perform the role of Lead Statistical Programmer for assigned projects • Continually seek ways and means to provide more efficient and effective programming practices • Develop specifications for SDTM datasets and SDTM datasets specifications for Clinical Data Analysis (CDA configuration) module in elluminate • Develop SAS programming to produce SDTM datasets and SDTM datasets for CDA configuration • Develop specifications for Analysis Data Model (ADaM) datasets • Develop SAS programming for ADaM datasets • Responsible for developing and maintaining programming and validation specifications for TLGs as per requirements provided by the Biostatistician • Create and maintain SAS programs to produce outputs to support the analysis and reporting of clinical trials • Develop analysis datasets for trial level reporting and integrated safety and efficacy activities • Program and QC data listings, summaries and Graphs as defined in SAP. If required, validate the statistical models used for programming • Develop re-usable utility macros in order to build a macro library to support programming tables, listing and graphs for phase 1-4 clinical trial reporting • Collaborate with the project team to ensure the deliverables are completed on time with high quality • Create submission-ready standard data presentations and data sets using standard coding and following standard industry processes including SDLC • Maintain all project documentation as required by SOP and Processes • Mentor statistical programmers • Ensure compliance with eClinical Solutions and industry quality standards, guidelines and procedures

🎯 Requirements

• Bachelor’s degree or equivalent work experience preferred • 5+ years in Pharmaceutical/Biotechnology industry or equivalent IT consulting role preferred • Strong experience in preparations for NDA filings • Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodologies • Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) • Knowledge of CDISC® related data models like SDTM, and ADAM • Experience of working on multiple clinical protocols at the same time • Excellent verbal and written communication skills • Detail oriented, ability to multitask with strong prioritization, planning and organization skills • Excellent team player • Experience of extracting, manipulating, merging, summarizing, analyzing and presenting data using SAS procedures • Strong experience of base SAS programming, Proc SQL, macro programming, ODS and various SAS modules: SAS/GRAPH, SAS/STAT and other modules like SAS/Connect and SAS/Access is a must • Experience with reporting environments and reporting tools related to SAS programming in pharmaceutical industry; proc report, proc summary and proc tabulate • Strong experience in SAS programming in various phases of clinical trials • Experience in pooled data analysis and programming • Strong experience in efficacy reporting with regards to development of analysis sets and treating missing values • Experience in working with relational databases and performance tuning of SAS programming • Experience with writing batch scripts and/or shell scripts is a plus

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options