Head of Biometrics
Calliditas Therapeutics AB / Chefsjobb / Stockholm
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Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing, and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 trial within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit
www.calliditas.com (
http://www.calliditas.com) for further information.
Position summary
As Head of Biometrics at Calliditas Therapeutics you will be responsible for creating and implementing the strategic direction for biostatistics, programming, and data management activities across all projects, in all phases of development. You will also be responsible for developing functional infrastructure and building biometric capabilities at Calliditas and, in collaboration with the Chief Medical Officer, will set or significantly influence the long-term strategic direction for Biometrics, in line with the company's broader clinical development strategy.
Key capabilities
• Demonstrates a long-term perspective that extends beyond the immediate initiatives; visualizes and articulates a clear direction for Calliditas Biometrics.
• Ability to clearly communicate complex statistical concepts and analysis outcomes in both written and oral communication, and competence in presenting to a wide variety of audiences including internal teams and external medical/scientific communities.
• Proven leadership ability, and demonstrated ability to work as a senior team member, engaging and influencing team members.
• Demonstrated problem-solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
• Strong interpersonal and communication skills, including fluency in written and spoken English.
• Lives the leadership behaviors of Calliditas employees: be positive, be accountable, be results-oriented and be an excellent manager of self and others.
Education and experience requirements
• Masters or PhD in statistics or related field
• 15+ years of experience in pharmaceutical, biotech, medical device industry or equivalent; global experience preferred.
• Experience leading a statistical or biometrics function is preferred.
• Experience in rare diseases is an advantage.
• Significant experience interacting with regulatory agencies.
• Prior people management experience and experience identifying organizational needs (talent, process, technology) are strongly preferred.
Reasons to join the Calliditas Team
• Be a part of a global leader in IgA- Nephropathy and a rapidly growing clinical-stage pharmaceutical company
• Be a part of the completion of the Nefegard trial and our focus to file for approval with the FDA and EMA
• Get in on bonus and benefit programs
• Fast-paced small company environment
Welcome to join the Calliditas Team!
Varaktighet, arbetstid
Heltid Anställningstid enligt överenskommelse
Publiceringsdatum2022-04-06ErsättningLön enligt överenskommelse
Så ansöker duSista dag att ansöka är 2022-09-23
Klicka på denna länk för att göra din ansökanFöretagCalliditas Therapeutics AB
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Calliditas Therapeutics AB (org.nr 556659-9766)
Arbetsplats Calliditas Therapeutics
Jobbnummer 6512326
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