Job SummaryAbout us
Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseasesThe role
As Senior Programmer at Genmab, you will be a key player in supporting the development of new therapies by ensuring integrity, consistency and adherence to standards of data. You produce well-structured, high quality data summaries in tables, figures and listings ready for decision making.
The programmer will support Data Management, Drug Safety, Medical and Clinical Pharmacology functions by developing and writing corresponding SAS programs.
As Senior Programmer you will be part of a growing team of programmers and statisticians that report to the Senior Director & Team Lead of Biometrics.
You will be working in an international environment with strong alliances outside Danish borders. Some traveling should be expected.Key accountabilities
- 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 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
- Performs 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
- 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
- Supports resource planning and outsourcing of programming activities
- Supports developing and reviewing standard processes and templates
- Minimum BSc. or equivalent qualifications
- Experience with the SAS software package and familiar with CDISC SDTM and ADaM data models: the corresponding structures and organizations of the data
- At least 4-5 years of experience within the pharmaceutical industry
- Experience working in a global context
- Proficient in both written and spoken English
Moreover, you meet the following personal requirements:
- As a person you are team-orientated and enjoy collaboration with both internal and external stakeholders
- You are detail orientated and able to write efficient, easily maintained and well documented computer programs
- You have a positive attitude, enjoy knowledge sharing and working on improving processes and systems
Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. 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 culture, all aiming to make a difference for cancer patients.
Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
If you would like additional information about this position before applying using the link, please contact Jannie Jensen, recruiter Genmab. firstname.lastname@example.org
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To learn more about Genmab, you can visit our website: http://www.genmab.com/