Penfield Search Partners
Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com
Job Description: Clinical Programmer is responsible for ensuring integrity, consistency and adherence to Study Data Tabulation Model (SDTM) standards, perform sponsor oversight of relevant programming activities on the Biometrics vendor, ensure the quality and consistency of data standards to support the portfolio towards the ultimate objective of data quality and consistency across programs and systems.
Responsibilities/tasks – including but not limited to:
- Implements and assists on developing company Study Data Tabulation Model (SDTM) standards that support the scientific need of a study/program while ensuring quality, consistency and compliance to CDISC standards and other industry standards that supports the exchange of data, reporting, and analysis
- Ensures alignment of SDTM standards with data collection standards and relevant company tools/system requirements by reviewing study eCRFs, supporting creation of external data collection standards, and providing SDTM mapping guidance
- Ensures study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality and integrity
- Creates quality control processes, metrics and other measures to ensure compliance with standards
- Ensures work carried out in accordance with applicable SOP’s and working practices, as well as global agency regulations/guidance’s
- Supports developing and reviewing standard processes and templates.
- Working with Digital Solutions and IT, support the implementation of future strategies and technology-enabled processes and tools for clinical trials standards, change control management and the exchange of standards information to internal downstream consumers and externally consumers
- Supports development of Dashboards by providing guidance on data structure, organization and contents of the SDTM-databases to the Dashboard developers and programmers
- Produce other in-house checks of data consistencies
- Contributes to knowledge sharing, skill building and good collaboration with stakeholders and colleagues
- Contributes to ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge
- Maintains up-to-date knowledge on relevant regulatory guidelines/requirements
- Maintains a good working relationship with stakeholders and colleagues
- Participates and represent clinical programming in teams and meetings
- Support oversight of vendor programming deliverables
Requirements – what is expected of you:
- Bachelor’s degree in Statistics, Computer Science, Life Sciences. Master’s degree in Statistics, Computer Science, Life Sciences preferred
- Has experience working in a global context
- Proficient in both written and spoken English
- At least 3-5 years of experience within the pharmaceutical industry
- Has experience with the SAS software package
- Competences and skills:
- SAS programming
- Analytical and problem-solving skills
- Expert knowledge of the CDISC SDTM data model: the corresponding structures and organizations of the data.
- Experience in oncology and medical affairs strongly preferred
- R experience a plus