Principal Biostatistician (m/f)

Division Global Drug Development
Geschäftseinheit CD&A GDD
Standort Oberhaching (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 245069BR


Stellenbeschreibung

• Responsible for all statistical tasks on assigned biosimilar trials, and perform these tasks independently seeking peer input / review as required.
• Responsible for protocol development in alignment with the development plan, developing statistical analysis plans, reporting activities.
• Contribute to planning and execution of exploratory analyses, and statistical consultation.
• Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician and GMA Group Head. This could include incorporating evidence from sources of big data, for example, digital technology and real world evidence.
• Explain statistical methodology and interpret analysis results. Provide statistical expertise to support Health Authorities requests and publications activities, as required. Develop statistical analysis plan for those requests.
• Contribute to interactions with external review boards / ethics committees, external consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings.
• Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness of status and issues related to the assigned trials.
• Collaborate with other line functions. Explain statistical concepts in manner easily understood by non-statisticians and provide adequate statistical justifications for actions / decisions / statements as required.
• Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team.
• Oversee all Biostatistics resources and deliverables for assigned trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities.
• Contribute to project level activities as needed.
• Contribute to initiatives at global line function level.
• Participate in non-clinical project activities as needed.



Research & Development


Mindestanforderungen

• MSc (in Statistics or equivalent) with 4+ years relevant work experience or PhD (in Statistics or equivalent) with relevant work experience (including internship)
• Fluent English (oral and written)
• Good communication and presentation skills
• Influences decisions that directly impact the assigned clinical trial and team ability to deliver objectives
• Experience in all tasks of a statistician at the trial / experiment level and demonstrated independence in the role
• Proven knowledge and expertise in statistics and its application to GMA trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in data exploration and data mining skills.
• Proficiency in use of statistical software packages (e.g. SAS, R)
• Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives
• Good knowledge of drug development and Health Authority guidelines
• Good understanding of Disease / Therapeutic Area and / or regulatory activities
• Demonstrated effectiveness working in a multidisciplinary team to achieve team objectives
• Good business ethics



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