(+45) 29 44 00 80 / kontakt@beirholmsearch.dk

Senior Statistical Programmer

Senior Statistical Programmer
august 20, 2019 Hanne Beirholm
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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.

The Role

As Senior Statistical Programmer at Genmab, you will be a key player in supporting the development of new therapies by ensuring integrity, consistency and adherence to data standards. You produce well-structured, high quality data summaries in tables, figures and listings ready for decision making.

You will support Data Management, Medical Writing, Drug Safety, Medical and Clinical Pharmacology functions by developing and writing corresponding SAS and/or R programs.

You will be working in an international environment with strong alliances outside Danish borders. Some traveling should be expected.

This is a fantastic opportunity to join Genmab – a highly innovative biotech company with a rich pipeline 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.

Key Accountabilities

As Senior Statistical Programmer you will be part of a growing team of programmers and statisticians that report to the Senior Director & Team Lead of Biometrics.

Your key responsibilities include but are not limited to:

  • Support in-house production of tables, figures and listings, by writing the corresponding programs and ensuring QC for deliverables such as IB, DSUR, briefing packages for FDA, EMA etc., response to authority requests for information, internal requests etc.
  • Perform sponsor oversight of programming activities by the biometrics vendor including checks of adherence to SDTM and ADaM standards
  • Support the establishment and maintenance of Genmab SDTM and ADaM database standards
  • Support specification and pooling of data across clinical
  • Review CRFs for adequacy and consistency
  • Perform QC on SAS/R-code written by other Genmab colleagues
  • Support submissions by ensuring that the programming-related part of the file is consistent with current electronic submission standards and guidelines
  • Support development of GenSense Dashboards by providing guidance on data structure, organization and contents of the Genmab SDTM-databases to the Dashboard-developers and programmers
  • Support resource planning and outsourcing of programming activities
  • Support development and review standard processes and templates

Skills and experience

You will have a minimum BSc or equivalent qualifications, and a minimum of 5-7 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.

Other

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.

 

Further Information:

If you would like additional information about this position before applying, please contact Beirholm Search, Hanne Beirholm tel. 29 44 00 80

For applying please  use the link,





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