Principal / Senior Principal Biostatistician
- Entreprise
- Novartis Pharma AG
- Lieu
- BASEL
- Date de publication
- 03.09.2025
- Référence
- 1248418
Description
Job ID
REQ-10060194
Sep 02, 2025
Switzerland
### Summary ###
The Principal / Senior Biostatistician is responsible for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team. May support project level deliverables for a development project with supervision. Leads implementation of modern and innovative clinical trial/experimental designs, statistical models, analyses and data exploration at the study level.
### About the Role ###
**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.
**Why Novartis:** Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients- lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
**Join our Novartis Network:** Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network (link is external)
**Why Novartis:** Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients- lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
**Join our Novartis Network:** Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network (link is external)
**Benefits and Rewards:** Read our handbook to learn about all the ways we-ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Division
Development
Business Unit
Innovative Medicines
Location
Switzerland
Site
Basel (City)
Company / Legal Entity
C028 (FCRS = CH028) Novartis Pharma AG
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
REQ-10060194
Sep 02, 2025
Switzerland
### Summary ###
The Principal / Senior Biostatistician is responsible for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team. May support project level deliverables for a development project with supervision. Leads implementation of modern and innovative clinical trial/experimental designs, statistical models, analyses and data exploration at the study level.
### About the Role ###
**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.
**Why Novartis:** Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients- lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
**Join our Novartis Network:** Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network (link is external)
**Why Novartis:** Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients- lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
**Join our Novartis Network:** Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network (link is external)
**Benefits and Rewards:** Read our handbook to learn about all the ways we-ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Division
Development
Business Unit
Innovative Medicines
Location
Switzerland
Site
Basel (City)
Company / Legal Entity
C028 (FCRS = CH028) Novartis Pharma AG
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.