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.
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 diseases.
As Associate Director,Programming 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.
You will support Data Management, Drug Safety, Medical and Clinical Pharmacology functions by developing and writing corresponding SAS programs.
You will be working in an international environment with strong alliances outside Danish borders.
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.
This is a newly established position and as Associate Director,Programming you will be part of a growing team of programmers that report to Director, Team Lead for Programming.
Your key responsibilities include but are not limited to:
- 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
- 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
- Reviews CRFs for adequacy and consistency
- 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 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
You will have a BSc or equivalent qualifications, and a minimum of 4-6 years’ experience as Programmer in the pharmaceutical/CRO industry preferably within the oncology therapeutic area.
Besides, you must have competence within the following areas:
- Experience with the SAS software package and familiar with CDISC SDTM and ADaM data models: the corresponding structures and organizations of the data
- 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
Besides all the personal and educational requirements, we need a person with a strong mindset. A person who wants to take responsibility, be a part of day-to-day work, prioritize tasks and the important from the less important, be a good role model, and spread knowledge. You must be adaptable to changing needs, changed plans and capable of handling a series of parallel tasks and discussions.
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.
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