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Statistical Programmer
Description:
Primary Responsibilities: This role reports to the Manager, Statistical Programming, and above Produces complex statistical analysis using SAS/R according to relevant standard operating procedures. Ensuring compliance to SOPs and internal process for the project managed Programming analysis dataset without specifications and review of SAS programs in the designated clinical trail Develop SDTM/ADaM specifications as per the company or client standards Ensure the project team delivers the projects within agreed timelines and quality standards. Ability to lead multiple studies (e.g., CSR, DMC, PSUR/DSUR, etc.) Developing SAS Programs for the complex statistical analysis of study data, including analysis of datasets, tables, listings, and figures Programming according to CDISC SDTM and ADaM datasets Review Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines Create an electronic submission package to FDA, e.g., Patient Profile or Subject Narratives, ISO Listings, define.xml, or define.pdf following FDA guidelines. Preparing and performing internal training on statistical programming processes and techniques. Support the less experienced team for technical issues Make certain that the study team ensures project documents and specifications are consistent and comply with company/client standards by providing the inputs into study SAP, Protocol, CRF, and outputs Provide guidance, mentoring, training for junior team members and help solve issues from cross-functional teams Represent ClinChoice/Department during internal and external audits Communicating effectively with the internal project team and global team. Collaborate closely with the study/working group. Anticipate/identify the risk or issues within the project and proactively communicate to the trial lead or manager Actively present lesson learning/ best practices/ best approaches in knowledge-sharing meetings, ask questions, and share feedback continuously to improve the process or standards of the programming. Proactively communicate and collaborate with the global team by understanding the time zone differences. Support the resourcing manager for effective resource allocation and team utilization within the study budget Drive innovative solutions or projects to improve the process or programming methodologies or patterns or solutions. Conducts other statistical programming activities as required Conduct other administrative and departmental activities as needed. Secondary Responsibilities: Align with deliverables and project metrics as per client SLA and/or as per internal metric parameters [examples: timelines, quality, etc.] Responsible to ensure training compliance and timesheet compliance• Be aware of and comply with the QMS/ ISMS & PIMS Policy. Report any potential or actual Security Breaches to the regional and/or global DPO & Security Incidents to CISO/ applicable distribution list.• Contribute towards the achievement of Quality Objectives Qualifications: Bachelor’s degree or equivalent required, preferably in life science, statistics, computer science, or related subjects. Should have a minimum of 9+ years of experience within the pharmaceutical industry. Extensive experience within the pharmaceutical industry with clinical programming and clinical development processes of across therapeutic areas. Comprehensive knowledge and experience in study setups, different processes, tasks such as SDTM, SDRG, ADaM, ADRG, TFL, ISS/ISE, Define XML, ISO Listings, Macro Programming, etc. and analysis the requirements for clinical programming projects. In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology, e.g., ICH-GxP, E3, E6, etc. Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc. Excellent written and verbal communication skills, collaborations, and interpersonal skills. Powered by JazzHR
Company:
Glints
Posted:
May 17 on The Resumator
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