This is a fantastic opportunity to join Genmab…..
Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.
The Senior Programming Manager checks complex data for consistency, and also aggregates and combines them into clearly organized tables, figures or lists, thus providing quality material which forms the basis for insights as well as informed recommendations and decisions to be made.
The Senior Programming Manager will support the Data Management, Statistics, Drug Safety, Medical and Clinical Pharmacology functions with the above by developing and writing corresponding SAS programs and documentation.
This position reports into the Director, Team Lead, Programming and is based Copenhagen, DK location.
This is a fantastic opportunity to join Genmab – a highly innovative biotech company with a rich pipeline and at the forefront of cancer therapy development.
It is a small organization with a short chain of command. You will have high visibility and possibility to influence. You will be part of defining and shaping the role of statistical programming in Genmab as the number of studies and amount of data grows.
- Work with the team to establish and maintain Genmab SDTM and ADaM database standards.
- Review CRFs for adequacy and consistency
- Perform database standard consistency checks on databases delivered by the preferred DM & Statistics vendor to Genmab.
- Create specifications and pool data across clinical trials within the same project.
- Produce tables, figures and listings in-house
- Perform sponsor oversight of programming activities on the DM & Statistics vendor
- Perform QC on SAS-code or other languages (eg. R, Python) written by other Genmab colleagues or partners.
- Support submissions by ensuring that the programming-related part of the file is consistent with current electronic submission standards and guidelines.
- Support resource planning and outsourcing of programming activities.
- Support developing and reviewing standard processes and templates.
- Contribute to knowledge sharing, skill building and good collaboration with stakeholders and colleagues
- Identify ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge
- Maintain up-to-date knowledge on relevant regulatory guidelines/requirements
- Participate and represent programming in teams and meetings
- Minimum of a Bachelor’s degree
- At least 4 years of Pharmaceutical/Biotech SAS programming experience
- Experience with SAS/Graph and SAS Macros is a plus
- Experience with the CDISC data models
- Experience in oncology is preferred
- NDA/BLA submission experience is a plus
- Ability to plan, organize and prioritize own tasks in a fast paced and changing environment
- Good oral and written communication skills
- Ability to work independently as well with global teams (internal and external)
- Result and goal-oriented and committed to contributing to the overall success of Genmab
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.
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.
Founded in 1999, the company is the creator of four approved antibodies. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab’s technology base consists of validated and proprietary next generation antibody technologies and intends to leverage these technologies to create opportunities for full or co-ownership of future products.
Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
If you have any questions, please feel free to reach out to Hanne Beirholm, Beirholm Search at +45 29440080
Please send your application on the following link.