Statistical Programmer Job Description Template
Our company is looking for a Statistical Programmer to join our team.
Responsibilities:
- Develop/validate and review of SDTM and ADaM data specifications;
- Works closely with other programmers to ensure the quality of all deliverables and project timelines are met;
- Work collaboratively with study biostatistician by reviewing and providing inputs for study statistical analysis plan and TFL shells;
- Provide statistical programming support to the clinical study team for all assigned clinical project;
- Ensure that all departmental standard operating procedures that govern any aspect of their work are adhered to;
- Prepare data submission packages including define.xml and data reviewers guide;
- Create/validate CDISC compliant SDTM and ADaM datasets by following data specification;
- Archive relevant documentation and deliverables;
- Perform other duties that may be requested by management as assigned;
- Review and provide comments on statistical analysis plan and data display documents;
- Review and provide feedback on Master Plan for assigned project;
- Review statistical analysis plan and data display documents as needed, to provide feedback on programming feasibility and efficiency;
- Assume responsibility for project study budget and perform monthly time projections for each project;
- Contribute to process improvement initiatives;
- Review and provide input to project timelines and ensure that project timelines are met for both internal and external clients.
Requirements:
- Oncology or/and regulatory submission experience preferred;
- Proven knowledge of clinical trials, CDISC standards, regulatory guidance, GCP, and ICH Guidelines;
- Good knowledge of SAS Base, SAS Graph and SAS Macro;
- Bachelor s degree with 5+ years or Master s degree with 3+ years of work experience in pharmaceutical/biotech or related industry;
- Must have good verbal and written communication skills;
- Good verbal and written communication skills;
- Advanced programming skills in data manipulation, statistical analysis, and reporting;
- Ability to manage multiple assignments in a timely fashion;
- Work well independently and in a team environment;
- Experience managing and analyzing large databases;
- BS in Economics, Statistics, or other related fields;
- Stata and SQL experience;
- Ability to interpret data and draw conclusions/make suggestions based on analysis;
- US Citizen.