Senior Manager / Associate Director, Clinical Programming
Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.
Genmab is hiring a Senior Manager or Associate Director, Clinical Programming reporting to the Princeton, NJ, US; Copenhagen, Denmark; or Utrecht, The Netherlands offices.
The Senior Programming Manager, Clinical Programming is responsible for the establishment, governance, and integrity of Study Data Tabulation Model (SDTM) standards, performs sponsor oversight of relevant programming activities on the Biometrics vendor, and ensures the quality and consistency of data standards to support the portfolio towards the ultimate objective of data quality and consistency across programs and systems. This new role reports to the Director, Team Lead of Clinical Programming.
The Associate Director, Clinical Programming is responsible for the establishment, governance, and integrity of clinical trial data standards, and acts as the statistical programming subject matter expert to oversee outsourced/internal SDTM programming activities to ensure the quality and consistency of clinical trial data standards to support the portfolio towards the ultimate objective of data quality and consistency across programs and systems. This new role reports to the Head of Programming.
The role will support the Data Management, Statistics, Drug Safety, Medical, and Clinical Pharmacology functions with the above by developing and writing corresponding SAS programs. Position level will be determined at management’s discretion.
Responsibilities/tasks - including but not limited to:
- Responsible for defining company Study Data Tabulation Model (SDTM) standards specifications working closely with implementation support teams (database set-up, completion guidelines, CRF designers, procedures, algorithm specifications and reporting requirements)
- 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 any needed documentation and training for standard processes, change control management and tools
- Facilitates a culture of continuous process improvement and a high level of customer service by maintaining and improving the standards processes associated with standards creation, maintenance, decision-making and implementation
- 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 GenSense Dashboards by providing guidance on data structure, organization, and contents of the Genmab SDTM-databases to the Dashboard developers and programmers
- Produce other in-house checks of data consistencies
- Supports submissions by ensuring that the programming-related part of the file is consistent with current electronic submission standards and guidelines
- Senior Manager - at least 6 years of relevant programming experience in the pharmaceutical/biotech industry required
- Associate Director - at least 9 years of relevant programming experience (Associate Director level) in the pharmaceutical/biotech industry required
- Minimum completed BSc. or equivalent qualifications
- Strong work experience with the SAS software package
- Demonstrated experience using relational databases in addition to SAS (e.g., MDR, MS SQL Server, MS Access, Oracle, or R)
- Has experience working in a global context
- Proficient in both written and spoken English
- Acts as a role model
- Proactively engages in department activities
- Arranges lessons learned to share learnings
- Leads various initiatives within the department
- Proactively contributes to support a global organization
- Acts as mentor for new employees or consultants
Competences and skills:
- SAS programming
- Analytical and problem-solving skills
- At Senior Manager level, expert knowledge of the CDISC SDTM data model: the corresponding structures and organizations of the data.
- At Associate Director level, expert knowledge of the CDISC SDTM and ADaM data models: the corresponding structures and organizations of the data. Proficiency with Medidata Rave.
- Contextual understanding of the data
- Writes efficient, easily maintained and well documented computer programs
- Is systematic and organized in writing and archiving computer programs
- Proactive and Accountable and Goal oriented
- Good team player
- Good at sharing knowledge
- Works independently, takes responsibility and shows initiative
- Good communication skills
- Good planning and coordinating skills
- Ability to flexibly work on multiple tasks without compromise of the quality of the work
Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.