Manager, Statistical Programming
Job creation – Permanent contract – Full time position
Reporting to the Clinical Data Manager, you will be accountable for ensuring programming activities to support data management and for supporting biostatistics activities.
Your main responsibilities are:
- Programming the integration of databases from multiple studies or sources for creation of global clinical databases,
- Appling programming and analytical skills to extract information from large datasets,
- Designing and developing programs in support of complex clinical analysis and reporting activities (e.g.: indicators for data monitoring),
- Contributing to the development of study protocols, statistical analysis plan (SAP), programming specifications and output documents,
- Reviewing and providing input on key study-related documents, such as case report form and CSRs,
- Reviewing and validating specifications and SAS programs to generate standards (SDTM and ADAM) and non-standard (custom study specific) datasets,
- Providing guidance and facilitating statistical analysis to scientists across the R&D team,
- Presenting results of statistical analyses and assists in the preparation of abstracts, manuscripts and/ or presentations to conferences,
- Contributing to improve operational efficiencies of workflows, including writing of internal guidance documents (e.g. SOP and quality management documents),
- May contribute to departmental innovation and process improvement projects.
You have a MSc, PhD or equivalent in statistics, biostatistics, epidemiology or in a related discipline.
You speak fluently English.
You have knowledge in Good Clinical Practices, Clinical Research, Clinical trial process and related regulatory requirements and terminology. You have also a good understanding of FDA/PMDA/ICH guidelines.
You should possess experience with industry data standards, such as CDISC SDTM/ADAM data models as well as experience with statistical methods for clinical research in pharmaceutical industry.
You have strong statistical programming skills in SAS and have demonstrated knowledge in standard statistical analysis methodologies.
You have extensive knowledge with industry standards such as the ICH guidelines, CDISC data structures, 21 CRF part 11 and FDA guidelines.
You have excellent communication and interpersonal skills to effectively interface with others team members and CRO.
Furthermore, you should possess strong analytical skills, pay attention to details and hardworking.
As part of our disability inclusion action plan, our company's hiring policy aims to improve the representation of employees with disabilities in its workforce.
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