Statistical Programming, Associate Director
This late clinical-stage oncology-focused biotechnology company is pioneering the development and commercialization of highly potent and targeted antibody drug conjugates 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 they have proprietary rights for its targets. Strategic target selection for PBD-based ADCs and substantial investment in early clinical development have enabled them 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).
This Associate Director position is responsible for leading projects/studies on creation/validation ADaM and TFLs through a life cycle of a study. Manage and monitor project and project team in ADaM and TFL over development and deliverable.
- In-depth knowledge of clinical trial development and conduct in biotech or pharmaceutical field. Solid knowledge of CDISC guideline, e-Submission and regulatory agency requirements.
- Oversee projects and manage project programming progression and timelines.
- Review eCRF, and SDTM annotated aCRF, protocol, SAP from analysis mapping perspective.
- Efficiently and effectively develop and validate ADaM, tables, listings and figures for all programming deliverables through the project milestones from study start-up to regulatory.
- Interact with SDTM and Statistician in ADaM and TFL generation or validation. Able to quickly identify data issue from analysis level and through TFL.
- Work and review submission package including ADaM related define, reviewer guide etc.
- Overview project level ADaM process to ensure consistency among studies.
- Ensure ADaM process compliance with CDISC guideline and monitor most recent IG, model and controlled terminology.
- Rapidly perform ad hoc or exploratory analysis, generate outputs according to the requirement.
- Contribute to the creation, maintenance, and validation of internal standards for programming tools, outputs and macros.
- Monitoring SDTM data transfers for ongoing trials to identify study conduct, data quality and new or change. Works with SDTM closely and recognizes inconsistencies and initiates resolution.
- MS in life science, statistics, mathematics, and computer sciences is preferred.
- Minimum 8 years of SAS programming experience within Pharma/Biotech/CRO.
- Advanced SAS programming skills in a clinical data environment with expertise in oncology area. Knowledge and experience on lymphoma, hematology and solid tumor is a plus.
- Thorough understanding of relational database structures and their correlation to submission ready database structures. Solid knowledge of CDISC data structure requirements.
- Experience in project management. Ability to effectively organize and manage multiple assignments with challenging timelines.
- Provide expertise in company-wide CDISC ADaM team and serve as a key member.
- Experience in delivering one or more submissions to regulatory authorities globally. Thorough knowledge of regulatory requirements concerning electronic submission standards.
- Proven ability to work collaboratively on interdisciplinary teams.
- Strong interpersonal skills that demonstrate initiative and motivation.
- Ability to problem solve.
- Excellent verbal and written communication skills in a global environment.
- Lead and validate studies/projects with attention to detail.