At a Glance
- Tasks: Lead statistical work for clinical trials, ensuring scientific integrity and data validity.
- Company: Join Novartis, a leader in innovative medicine and an inclusive employer.
- Benefits: Enjoy hybrid work options and a supportive, diverse workplace culture.
- Why this job: Make a real impact on patients' lives while collaborating with passionate professionals.
- Qualifications: MS or PhD in Statistics with relevant experience; strong communication skills required.
- Other info: Work 3 days a week in our London office and be part of a dynamic team.
The predicted salary is between 54000 - 84000 £ per year.
Job Description
This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Summary -Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. About the Role
Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives.
To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic areas and platform depth and capabilities – all to bring our medicines to patients even faster.
We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.
Apply today and welcome to where we thrive together!
The Role:
The Senior Principal Biostatistician is responsible and accountable for all statistical work, scientific and operational, for one or more assigned clinical trials in collaboration with the clinical trial team/global clinical team (GCT). You will work independently at the clinical trial level and may lead indication-level or project- level statistical activities for a drug development project under limited supervision. You will propose and lead implementation of modern and innovative trial/experimental designs, statistical models, analysis and data exploration methodologies at the study or project level.
This role may be in Early Development, Preclinical or Global Medical Affairs .
Key requirements:
- Responsible for all statistical tasks on the assigned clinical trials and perform these tasks for mid- to high complexity trials independently with peer review/input as required. Responsible for protocol development in alignment with the clinical development plan, developing statistical analysis plan, study and indication-level 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 de-signs in alignment with the Lead Statistician.
- Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, significantly contributing to meetings with and responses to Health Authorities and other drug development activities, as required.
- Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate.
- Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the trials.
- Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required.
- Establish and maintain collaborative relationships and effective communications cross- functionally within the Clinical Trial Team and Biostatistics & Pharmacometrics team.
- Ensure all Biostatistics deliverables for assigned clinical trials and/or non-clinical related activities are delivered in a timely manner with the highest level of quality.
- Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors.
Your Experience:
- MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 3+ years' relevant work experience.
- Fluent in English with strong communication and presentation skills.
- Influences decisions that directly impact the trial/project and team ability to deliver objectives.
- Demonstrable experience in all tasks of a statistician at trial and experiment level with the ability to work independently.Demonstrable knowledge and expertise in statistics and its application to clinical trials; ability to explain statistical designs and concepts. 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).
- Good knowledge of drug development and Health Authority guidelines.
- Demonstrated efficiency working on a multidisciplinary team to achieve team objectives.
- Understanding of Franchise/Therapeutic Area and/r regulatory activities.
- Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions.
- This role offers hybrid working, requiring 3 days per week or 12 days per month in our London Office.
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
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
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
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
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
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Senior Principal Biostatistician employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Principal Biostatistician
✨Tip Number 1
Make sure to familiarize yourself with the latest statistical methodologies and innovative trial designs. Being able to discuss these topics confidently during your interview will demonstrate your expertise and alignment with Novartis' goals.
✨Tip Number 2
Network with current or former employees of Novartis, especially those in biostatistics or related fields. They can provide valuable insights into the company culture and expectations, which can help you tailor your approach.
✨Tip Number 3
Prepare to discuss your experience with regulatory submissions and how you've contributed to successful outcomes in past projects. This is crucial for demonstrating your ability to support Novartis' clinical development efforts.
✨Tip Number 4
Showcase your communication skills by practicing how to explain complex statistical concepts in simple terms. This will be important for collaborating with non-statistical functions within the team.
We think you need these skills to ace Senior Principal Biostatistician
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Principal Biostatistician position. Highlight key responsibilities and requirements that resonate with your experience, especially in statistical methodologies and clinical trials.
Tailor Your CV: Customize your CV to reflect your relevant experience in biostatistics, particularly focusing on your expertise in clinical trials, statistical analysis, and any specific software like SAS or R. Use keywords from the job description to align your skills with what Novartis is looking for.
Craft a Compelling Cover Letter: Write a cover letter that not only summarizes your qualifications but also demonstrates your passion for improving patient outcomes through innovative statistical methods. Mention how your background aligns with Novartis' mission and values.
Highlight Collaborative Experience: Emphasize your ability to work within multidisciplinary teams. Provide examples of how you've successfully collaborated with non-statistical functions and contributed to achieving team objectives, as this is crucial for the role at Novartis.
How to prepare for a job interview at Novartis
✨Showcase Your Statistical Expertise
Be prepared to discuss your experience with statistical methodologies and how you've applied them in clinical trials. Highlight specific examples where your statistical analysis led to significant insights or decisions.
✨Understand the Drug Development Process
Familiarize yourself with the drug development lifecycle and regulatory requirements. Be ready to explain how your role as a biostatistician fits into this process and how you can contribute to successful submissions.
✨Communicate Clearly with Non-Statisticians
Practice explaining complex statistical concepts in simple terms. This will demonstrate your ability to collaborate effectively with cross-functional teams and ensure that everyone understands the data-driven decisions being made.
✨Prepare for Behavioral Questions
Expect questions about teamwork, leadership, and problem-solving. Use the STAR method (Situation, Task, Action, Result) to structure your responses and provide concrete examples of how you've successfully navigated challenges in previous roles.