Senior Programming Associate / Programming Manager (Hybrid or Remote)

The Senior Programming Associate / Programming Manager supports the development of new therapies by ensuring integrity, consistency, and adherence to standards of data and produces well-structured, high quality data summaries in tables, figures, and listings for decision making.

The Senior Programming Associate / Programming Manager will provide support to the Lead programmer and will at times work with Data Management, Statistics, Drug Safety, Medical, Clinical Pharmacology and Biomarker functions by developing and writing corresponding SAS or other programs.

Responsibilities/tasks - including but not limited to :

• Reviews CRFs for adequacy and consistency

• Supports the establishment and maintenance of Genmab SDTM and ADaM database standards.

• Performs database standards consistency checks on databases delivered by the preferred DM & Statistics vendor to Genmab.

• Produces other in-house checks of data consistencies

• Supports specification and pooling of data across clinical trials within the same project. Supports in-house production of analysis datasets, tables, figures and listings, by writing the corresponding programs and ensuring QC before formal release, for the following non-comprehensive list of deliverables: IB, DSUR, briefing packages for FDA, EMA etc., supplementary in-house preparations for DMC-meetings, RP2D-selection preparations, supplementary material for interim analysis and final analyses (e.g. sub- group or other analyses not pre-defined in the SAP), answers to questions posed by regulatory authorities or ethics committees, answers to in-house questions related to data quality, safety monitoring, medical questions etc.

• Aid in sponsor oversight of programming activities on the DM & Statistics vendor

• Performs QC on SAS-code written by other Genmab colleagues

• Supports submissions by ensuring that the programming-related part of the file is consistent with current electronic submission standards and guidelines.

• Provide feedback on application development within the department when requested.

• Supports resource planning and outsourcing of programming activities.

• Supports developing and reviewing standard processes and templates.

• 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

• Contributes to process improvements

• Maintains up-to-date knowledge and competencies within relevant therapeutic and professional areas

• Maintains up-to-date knowledge on relevant regulatory guidelines/requirements

• Maintains a good working relationship with stakeholders and colleagues

• Participates and represent programming in teams and meetings

Requirements - what you must have

• Has experience with the SAS software package and other programming languages (such as R and Python)

• Minimum Bachelor of Science degree or equivalent qualifications

• Proficient in both written and spoken English

• At least 2 years of experience within the pharmaceutical industry as a Programmer (for Senior Programming Associate level)

As Senior Programming Associate / Programming Manager, it is expected that the employee:

• Acts as a role model

• Proactively engages in department activities

• Supports lessons learned to share learnings

• Participate in agreed upon initiatives.

• Proactively contributes to support a global organization

Competences and skills:

• SAS programming

• Analytical and problem-solving skills

• Knowledge of the CDISC, SDTM, and ADaM data models, including the corresponding structures, and organizations of the data

• Contextual understanding of the data

• Write efficient, easily maintained, and well - documented computer programs

• Is systematic and organized in writing and archiving computer programs

• Thorough

• Proactive, Accountable, and Goal-Oriented

• Innovative