Founded in 2011, ADC Therapeutics is a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients suffering from hematological malignancies and solid tumors. The Company develops ADCs by applying its decades of experience in this field and using next-generation pyrrolobenzodiazepine (PBD) technology to which ADC Therapeutics has proprietary rights for its targets. Strategic target selection for PBD-based ADCs and substantial investment in early clinical development have enabled ADC Therapeutics to build a deep clinical and research pipeline of therapies for the treatment of hematological and solid tumor cancers with significant unmet need. The Company has multiple PBD-based ADCs in ongoing clinical trials, ranging from first in human to pivotal Phase 2 clinical trials, in the USA and Europe, and numerous preclinical ADCs in development.
The Company has recently successfully completed an initial public offering (IPO) and its commercial organization is building the pre-launch market activities. There are operations in Lausanne Switzerland (Head office and Clinical), London UK (R&D), New Jersey US (Clinical and Commercial) and San Francisco US (CMC manufacturing). For more information please visit the company website www.adctherapeutics.com.
This Senior Programmer position is responsible for mapping analysis ADaM dataset, creating and validating tables, listings and figures from SDTM datasets for Phase I - III oncology clinical trials.
Review eCRF and SDTM annotated aCRF, protocol, SAP from analysis mapping perspective.
Create ADaM analysis datasets mapping specification.
Development and validation ADaM dataset using SAS.
Development and validation tables, listings and figures using SAS.
Interact with SDTM programmers towards ADaM generation.
Interact with statistician in ADaM and TFL generation and validation.
Find data issue at analysis level during ADaM, TFL and report to data management.
Work and review submission package including ADaM related define, ADRG, review guide etc.
Ensure ADaM process compliance with CDISC guideline and monitor most recent IG, model and controlled terminology.
Interact with Statisticians and clinical team, perform ad hoc analysis and generate outputs according to the requirements.
MS in life science, statistics, mathematics, and computer sciences is preferred.
Minimum 3 years of SAS programming experience within Pharma/Biotech/CRO.
Experience with CDISC ADaM is a must.
Good SAS programming skills and attention to detail are essential.
Experience in mapping oncology data. Knowledge of lymphoma, hematology and solid tumor is a plus.
Highly motivated and able to work well independently as well as being a good team player.
ADC Therapeutics SA