Senior Programming Manager
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Hellerup
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 Role
As Senior Programming Manager 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 Senior Programming Manager, will support Data Management, Drug Safety, Medical and Clinical Pharmacology functions by developing and writing corresponding SAS programs.
As Senior Programming Manager, you will be part of a growing team of programmers and statisticians that report to the Senior Director & Team Lead of Biometrics in the US.
You will be working in an international environment with strong alliances outside Danish borders. Some traveling should be expected.
Responsibilities:
• 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
Requirements:
• 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:
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.
More information, application:
If you have any questions, please feel free to reach out to Hanne Beirholm, Beirholm Search at +45 29440080
Or [email protected]
Please send your application on the following link.
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 Role
As Senior Programming Manager 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 Senior Programming Manager, will support Data Management, Drug Safety, Medical and Clinical Pharmacology functions by developing and writing corresponding SAS programs.
As Senior Programming Manager, you will be part of a growing team of programmers and statisticians that report to the Senior Director & Team Lead of Biometrics in the US.
You will be working in an international environment with strong alliances outside Danish borders. Some traveling should be expected.
Responsibilities:
• 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
Requirements:
• 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:
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.
More information, application:
If you have any questions, please feel free to reach out to Hanne Beirholm, Beirholm Search at +45 29440080
Or [email protected]
Please send your application on the following link.
Hanne Beirholm
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Hellerup.
Jobbet er oprettet på vores service den 19.5.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Hellerup
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