Principal Statistical Programmer
cGxPServeSan Diego, California, USAjob_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionMust have expertise in SAS / BASE SAS / STAT and knowledge of SAS / CONNECT SAS / ACCESS SAS / MACRO SAS / GRAPH SQL and ODS. Knowledge of SDTM ADaM FDA and ICH guidance Understanding of Code of Federal Regulations (CFR) Title 21 Part 11 that covers the management of electronic records and electronic signatures in computer systems. Good organizational skills across individual projects and managing own and teamwork loads. Ability to organize manage and complete multiple assignments with challenging timelines independently and effectively. Consistent experience as a lead statistical programmer on several concurrent projects. Strong understanding of drug development including knowledge of interfaces and interdependencies with other functions. Strong mentoring skills as shown by leadership of projects and if applicable junior team members. Excellent analytical skills. Proven ability to learn new systems and function in an evolving technical environment. Ability to negotiate and influence to achieve results. Good presentation skills. Good business awareness / business development skills (including financial awareness). Ability to create maintain and define strategies to improve the efficiency of running a clinical trial. Work effectively in a quality-focused environment. Knowledge of other programming languages and database management software packages is a plus.
Responsibilities :
- Convert specifications into SAS code to generate datasets and Tables Listings and Figures outputs.
- Be responsible for overall project delivery including clinical trial reports and other regulatory submission deliverables.
- Create statistical analysis outputs to be used in support of final reports abstracts posters Manu scripts and other clinical publications; support systems to produce electronic regulatory submissions.
- Assist in establishing standardized programming procedures and work instructions.
- Develop enhance evaluate and validate standardized macros and utility programs to ensure that regulatory requirements are met through validation / compliance activities.
- Develop and maintain clinical processing workflow systems.
- Assist in the development of client proposal documents.
- Provide leadership project specific training stakeholder management external sponsor support resource management and project management for the required programming tasks supporting clinical trial activities.
- Provide input into and negotiate statistical programming timelines. Ensure that timelines are adhered to and coordinate and lead a statistical programming team to successful completion of a study within given timelines and budgets.
- Trained in sponsor SOPs and disseminate knowledge to project team members as appropriate.
- Provide input into and mentor statistical programmers to provide input into documents produced by other functions (e.g. biostatisticians data managers medical writers etc.)
- Records handling (e.g. Chapter 21 of the US Code of Federal Regulation Part 11) and electronic submission of clinical data to agencies (e.g. e-CTD guidance and CDISC SDTM and ADaM standards).
- Assist in updating / writing PROMETRIKA standard operating procedures (SOPs).
- Develop tools in SAS for data analysis and reporting that comply with regulatory requirements.
- Develop specifications (e.g. metadata files) annotate CRFs and create SAS programs for the mapping of raw datasets to CDISC SDTM standards.
- Create files from metadata files for SDTM and ADaM.
- Convert data received in other formats to SAS datasets.
Requirements :
Key Skills
Business Development,Customer Service,Attorney,CISSP,Data Analysis
Employment Type : Full-time
Experience : years
Vacancy : 1
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Statistical Programmer • San Diego, California, USA