What are the responsibilities and job description for the Statistical Programmer position at Lprs?

A statistical programmer creates statistical programming deliverables. You ensure excellent programming of analysis-ready data, tables, and figures. You may use Stata for general purpose statistical analysis or SPSS for interactive or batched statistical analysis. Your responsibilities include developing standard operating procedures and complying with guidelines. Other duties include remaining informed on developments in programming standards and meeting all regulatory requirements. You also create PROC statements that call upon named procedures for analysis. You develop programs for dataset integration, prepare resource plans, and assist with quality control of datasets.

Our client is looking for a Statistical Programmer to join the 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.

Qualifications

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;

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Statistical Programmer

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