Head of Biostatistics
Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger
Hellerup
The Biostatistics team plays a critical role in advancing the new medicines at Genmab and as Head of Biostatistics you will be accountable for all statistical activities of the development of our innovative pipeline within oncology.
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
The Biostatistics team plays a critical role in advancing the new medicines at Genmab and as Head of Biostatistics you will be accountable for all statistical activities of the development of our innovative pipeline within oncology.
You will be responsible for defining the strategy and the processes within the statistical area, which includes driving innovative and efficient trial designs, clinical trials conduct and submissions, and ensuring innovation, quality and scientific validity of our trials.
You will ensure design, data analysis and interpretation (particularly regulatory and marketing claim substantiation, during clinical evaluations, studies, and trials) are high quality and in compliance with regulatory body standards.
As Head of Biostatistics you will lead a team of 7 highly competent and experienced Biostatisticians. It is essential that you can lead and inspire a highly engaged and committed team.
You will be part of the Clinical Operations Leadership Team (COLT) defining the overall strategy and development areas within Clinical Operations and partner with senior management, clinicians, pharmacologists, and translational research to support clinical development within Oncology.
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 shape not only the role but add a footprint on the pipeline – so is it time to take the next important step in your career?
Main Responsibilities
Qualifications
A team player, enthusiastic, passionate about bringing important new innovative products to patients with oncology. Actively continue to further build the group of highly qualified Biostatisticians.
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
The Biostatistics team plays a critical role in advancing the new medicines at Genmab and as Head of Biostatistics you will be accountable for all statistical activities of the development of our innovative pipeline within oncology.
You will be responsible for defining the strategy and the processes within the statistical area, which includes driving innovative and efficient trial designs, clinical trials conduct and submissions, and ensuring innovation, quality and scientific validity of our trials.
You will ensure design, data analysis and interpretation (particularly regulatory and marketing claim substantiation, during clinical evaluations, studies, and trials) are high quality and in compliance with regulatory body standards.
As Head of Biostatistics you will lead a team of 7 highly competent and experienced Biostatisticians. It is essential that you can lead and inspire a highly engaged and committed team.
You will be part of the Clinical Operations Leadership Team (COLT) defining the overall strategy and development areas within Clinical Operations and partner with senior management, clinicians, pharmacologists, and translational research to support clinical development within Oncology.
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 shape not only the role but add a footprint on the pipeline – so is it time to take the next important step in your career?
Main Responsibilities
- Oversee, mentor, and help develop a group of internal Biostatisticians and Consultants.
- Core member of scientific teams responsible for determining strategy and delivering results in a timely and high quality environment.
- Develop and implement strategy for the improvement of productivity and standardizing of biostatistical activities.
- Interface closely with Statistical Programming and Data Management to ensure end to end data quality.
- Bring innovative statistical thinking and methods to help drive the enhanced drug discovery and development, and lead initiatives that improve understanding and application of statistical methods utilizing simulation, Bayesian methods etc. to design efficient trials and co-development of companion diagnostics.
- Provide guidance on appropriate design, management, analysis and reporting of RWE trials.
- Interact with regulatory agencies to support accelerated clinical development options.
- Contribute to planning of submissions, and post-submission strategies, preparations and defences.
- Lead initiatives to improve understanding and application of statistical methods.
- Strong insight into the Business needs and seek out areas where statistics add most value to maximize success of our compounds.
- Ensure that flexible and rapid responses are provided for statistical requests.
- Identify and assist in the resolution of bottlenecks for study/project teams.
- Manage resources, set priorities, and ensure consistency and adherence to standards therein.
- Represent Biostatistics in the Protocol Review Committee (PRC)
- Drive/establish the creation/maintenance of state of the art processes and SOPs within the biostatistical areas.
- Development of specifications/requirements for outsourcing activities related to the biostatistical area and overall accountable for oversight of activities provided by consultants, CRO´s and other vendors.
- Shape Biostatistics function to create and leverage programs, policies, and procedures to provide value-adding solutions.
- Ensure that all teams and employees work toward the same objectives and work as one team
- Stay up to date on the latest relevant scientific literature and translate your learning into evolving best practices at Genmab.
- Identify external statistical experts for consultation.
- Act as key statistical consultant within Genmab.
- Represent the Biostatistical group in cross functional working groups.
- Promote collaborative relations with stakeholders, vendors, consultants, and CRO´s in a global setting.
- Work collaboratively with colleagues /partners in the EU, the US and Japan and bring cultural diversity into play.
Qualifications
- At least 10 years of experience in pharmaceutical development and applied biostatistics, oncology experience preferred.
- At least 5 years of management experience leading biostatistics group.
- Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred.
- Knowledge of FDA, EMA, and ICH guidance for drug development pertaining to statistics
- Experience with the relevant regulatory requirements for biostatistics processes and SOPs
- Experience with regulatory submissions including BLAs and previous experience in dealing with health authorities such as discussions/negotiations in filing strategies
- Familiarity with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions
- Demonstrated ability to work independently, handle multiple priorities within timelines, and collaborate with other functions to resolve issues and improve efficiency
- Excellent inter-personal skills in management, collaboration, and communication to managers, colleagues, team members, CROs, external statistical / medical experts, and external collaborators
- Strong communication skills with the ability to influence widely and work collaboratively with clinical project teams and senior management are required.
- “Go do” attitude, creative, proactive, enthusiastic, “outside-the-box” and goal orientated.
- Significant experience in managing to deliver results.
- Demonstrated ability to collaborate with a diverse and global group of people including but not limited to biostatisticians, clinicial, scientists, translational research
A team player, enthusiastic, passionate about bringing important new innovative products to patients with oncology. Actively continue to further build the group of highly qualified Biostatisticians.
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Hellerup.
Jobbet er oprettet på vores service den 7.11.2019, 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.
- Afdelingsleder
- Hellerup
Lignende jobs
-
Erfaren viceskoleleder til Arenaskolen i Greve
Fri kontaktTrivsel, faglighed, respekt, ansvar og fællesskab er nøgleordene i Arenaskolens værdigrundlag. Vores elevgruppe kan noget helt særligt, og på Arenaskolen er alle voksne vigtige voksne. Her er højt til loftet, og arbejdet med læring og dannelse er uadskilleligt.Få mere info- Afdelingsleder
- Greve
-
Afdelingsleder for Støtte, Vejledning og Forebygge...
Fri kontaktVil du være med til at skabe positive forandringer for borgere med udfordringer inden for det psykiatriske og sociale område? Vi søger en engageret og nærværende afdelingsleder, der kan stå i spidsen for flere tilbud til borgere i egen bolig som har brug for støtte og vejledning. Om os.Få mere info- Afdelingsleder
- Greve
-
2 afdelingsledere søges til Botilbud i Pædagogisk ...
Fri kontaktVil du være med til at skabe positive forandringer for borgere med autismespektrumforstyrrelser eller multihandicappede unge? Vi søger 2 engagerede og nærværende afdelingsledere, der kan stå i spidsen for både opstarten af nye tilbud og ledelse af eksisterende. Om os.Få mere info- Afdelingsleder
- Greve
-
Viceskoleleder
Fri kontaktViceskoleleder til Holmeagerskolen i Greve. Vil du være med til at lede en skole med stærke værdier? Fællesskaber, nysgerrighed og livsduelighed – det er de tre grundlæggende værdier på Holmeagerskolen i Greve. Hvis de værdier fænger, så læs videre! Holmeagerskolen er en 3-sporet skole med ca. 80 ansatte.Få mere info- Afdelingsleder
- Greve
Statistik over udbudte jobs som afdelingsleder i Hellerup
Herunder ser du udviklingen i udbudte afdelingsleder i Hellerup over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal afdelingsleder.
Se flere statistikker her:
Statistik over udbudte afdelingsleder i Hellerup over tid
| Dato | Alle jobs som afdelingsleder |
|---|---|
| 26. december 2024 | 1 |
| 25. december 2024 | 1 |
| 24. december 2024 | 1 |
| 23. december 2024 | 1 |
| 22. december 2024 | 1 |
| 21. december 2024 | 1 |
| 20. december 2024 | 1 |
| 19. december 2024 | 1 |
| 18. december 2024 | 1 |
| 17. december 2024 | 1 |
| 16. december 2024 | 1 |
| 15. december 2024 | 2 |
| 14. december 2024 | 2 |
| 13. december 2024 | 2 |
| 12. december 2024 | 2 |
| 11. december 2024 | 2 |
| 10. december 2024 | 3 |
| 9. december 2024 | 3 |
| 8. december 2024 | 2 |
| 7. december 2024 | 2 |
| 6. december 2024 | 2 |
| 5. december 2024 | 2 |
| 4. december 2024 | 2 |
| 3. december 2024 | 2 |
| 2. december 2024 | 2 |
| 1. december 2024 | 2 |
| 30. november 2024 | 2 |
| 29. november 2024 | 2 |
| 28. november 2024 | 3 |