Principal Statistical Programmer
Principal Statistical Programmer
Posted on :
22-08-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
22-08-2025
Job Description
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.
- Must 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.
Employment Type
Full-time
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