Major accountabilities:

• Responsible for all statistical tasks on assigned 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/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician.
• Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required.
• 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 as-signed 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.

Minimum Requirements:

• MS (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.
• Can influence decisions that directly impact the assigned clinical trial and team ability to deliver objectives.
• Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills.
• Proficiency in use of statistical software packages (e.g. SAS, R). Knowledge of drug development and Health Authority guidelines. Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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