Skills

Research Programming Process Improvement

Job Specifications

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***

About the Company

At PE Global, a leading international recruitment agency, we work closely with our candidates to ensure that the opportunities they are considering are the best ones available. PE Global is a resourcing company, with offices in Cork, Dublin, London and India that specializes in offering tailored recruitment solutions to companies and organisations in the domestic and international markets. At PE Global we have been providing cost effective, efficient and customised recruitment services to projects of all sizes since 2005 a... Know more