Statistical Programmer
Posted Today by PE Global
Negotiable
Undetermined
Remote
United Kingdom
Summary: The Statistical Programming Manager role involves providing comprehensive programming support for clinical trials at a leading multinational pharmaceutical company. The position requires managing programming components, ensuring compliance with regulatory standards, and delivering high-quality outputs within timelines. The role is fully remote within the UK and focuses on both independent project management and collaboration with cross-functional teams. Candidates must possess relevant educational qualifications and experience in the pharmaceutical or clinical research setting.
Key Responsibilities:
- Provide comprehensive programming support, including development of programs and ADaM specifications.
- Manage and deliver assignments with good quality and within timelines.
- Provide programming support to CDISC based e-submission.
- Develop, debug, and enhance SAS programs for quality control of datasets and TLFs.
- Implement programming standards and comply with regulatory requirements.
- Standardize GSD deliverables across study projects within an indication/therapeutic area.
- Communicate proactively about issues impacting programming deliverables.
Key Skills:
- Bachelor’s or Master’s Degree in Science, Statistics, Information Technology or equivalent.
- 5 years of experience with a Bachelor's or 4 years with a Master's in a pharmaceutical or clinical research setting.
- Proficient knowledge of clinical trials and drug development processes.
- Strong understanding of SDTM, ADaM standards, and implementation guides.
- Proficiency in using SAS and other software applications (e.g., Pinnacle 21, XML, MS Office).
- Ability to work independently and in a team environment.
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
PE Global are currently recruiting for a Statistical Programming Manager for a 23 month contract role with a leading multinational Pharma client based in Harlow – Fully remote within the UK. The Clinical Programming is responsible for providing comprehensive programming support, including managing the timely and accurate execution of programming components of clinical trials. The clinical programming contractor independently manages completed projects that involve global tasks, or cross functional teams The role may require providing inputs to design and analysis, and reporting the results of clinical trials, including programming rules and mocked T/L/G. In addition, providing programming support for publication for our marketed drugs.
Job Responsibilities
- Primarily works at the Study, product / program level
- Provides comprehensive programming support, including development of programs, ADaM specifications, analysis (datasets, TLFs) complying with regulatory requirements, departmental SOPs and work practices.
- Manages and Delivers assignments with good quality and within timelines.
- Provides programming support to CDISC based e-submission.
- Develop, debug, and enhance SAS programs to support quality control of safety or efficacy derived datasets and TLFs.
- Implement programming standards and comply with regulatory requirements among project team members and across all projects; communicate to management on project status and resource gaps.
- Responsible for the standardization of GSD deliverables (TLGs, Datasets) across study projects within an indication/therapeutic area.
- Provides input on opportunities for process improvement
- Proactively communicates issues impacting programming deliverables with Stat or DM team members.
Requirements
- Bachelor’s Degree/Master’s Degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
- Bachelors + 5 year, Masters + 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer.
- Proficient knowledge of clinical trials and drug development process, industry standards, statistical concepts used in analysis and submissions of clinical trial data.
- Strong understanding of SDTM, ADaM standards and Implementation guides.
- Demonstrated proficiency in using SAS to produce analysis datasets, TLFs, eSUB components and using other software applications (eg. Pinnacle 21, XML and MS Office)
- Demonstrated ability to work independently and in a team environment.
Interested candidates should submit an updated CV. ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***