location_onBengaluru, Karnataka, India
watch_later Posted: Jul 18, 2024
Skills Required
Nice To Have skills
Job Description
Principal Duties Responsibilities
- Perform and implement, under supervision, the following for clinical studies: (i) the SAS programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, listings, and graphs and (ii) the programming of analysis datasets (derived datasets) and transfer files for internal and external clients and (iii) the programming quality control checks for the source data and report the data issues.
- Provide technical expertise in conjunction with internal and external clients.
- Develop programming documentation including specifications, as appropriate, under supervision.
- Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables.
- Support other programmers within the DMC Statistical Center staff.
- Understand and follow standard operating procedures for the independent statistical center
- Assist in Department and Company projects as they relate to Biostatistical Services.
- Provide coverage within the team and other teams as needed.
- Other duties as assigned.
Job Requirements
Education
Bachelor's degree required, Masters degree preferred, in computer science, mathematics, statistics or related fields.
Experience
- Minimum of 1 year of recent experience with Statistical Programming, in SAS environment.
- Experience in pharmaceutical or medical devices industry preferred.
Knowledge, Skills, Abilities
- Must have working understanding and expertise in SAS® Base, SAS® graph, and SAS® Macros.
- Capable of implementing statistical procedures as per specifications provided by biostatistician.
- Must have working knowledge of CDISC standards (SDTM and ADaM)
- Basic understanding of clinical trial data and be able to work hands on in data manipulations, analysis and reporting of analysis results.
- Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and clinical research processes.
- Ability to work on multiple projects, plan, organize and prioritize activities.
- Ability to communicate effectively verbally and in writing in English.
- Excellent interpersonal skills to work effectively with others and provide high levels of customer service.
- Ability to follow instructions and work independently as required; plan, organize, schedule and complete work within competing deadlines and priorities.
- Ability to adapt to changes in office technology, equipment, and/or processes.
- Demonstrated consistency and dependability in attendance, quantity and quality of work.
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