Principal Biostatistician

Job Description Summary

Unique PhD Graduate Program – Virtual Analytics Network (Remote or Hybrid)
15 months rotating across 3 key areas of the Novartis Advanced Quantitative Sciences Organization.
Novartis continues to accelerate its growth in the data and digital space. As part of our continued growth, we are hiring PhD graduates into our Advanced Quantitative Sciences community who will start their career with 15 months rotating across 3 key areas of the organization. You will have the opportunity to work in different disease areas and phases of drug development, and then at the end of your rotations you will have a strong voice in selecting the area in which you will work permanently! We are excited to offer this unique opportunity to join a group of innovative PhD graduates working within our Virtual Analytics Network in the UK and Ireland. This is a truly unique PhD Graduate Program.
During your rotations, you will use your strong quantitative skills and curious mindset to provide expert support to clinical trials in early or late phase clinical development and/or exploratory analyses. Throughout, you will be supported with structured training and a buddy system, plus you will have the opportunity to meet and collaborate with colleagues in other locations.
Once you have completed your rotations, in your permanent role as a Principal Biostatistician you will be responsible for all statistical work relating to one or more assigned trials in collaboration with the Clinical Trial Team. You may also, with appropriate supervision, support project level goals.

Job Description

Major responsibilities:

• All statistical tasks on assigned trials, where you will be expected to perform these tasks independently, seeking peer input/review as required. Tasks may include: protocol and statistical analysis plan development; reporting activities; contributing to the planning and execution of exploratory analyses and/or PK, PK/PD analyses; exploratory biomarker and diagnostic analyses; statistical consultation.
• You will be responsible for initiating, driving and implementing novel methods and innovative trial designs in alignment with the Lead Statistician.
• Explaining statistical methodologies and interpreting analysis results. You will provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities.
• Contributing to interactions with external review boards, ethics committees, external consultants, and other external parties with oversight. You may represent Novartis in statistical discussions at external congresses, conferences or scientific meetings.
• Representing the Advanced Quantitative Sciences line function in multi-functional teams for the assigned trials. You will have responsibility for ensuring functional alignment and line function awareness of the status and issues related to the assigned trials.
• Collaborating with other line functions. You will explain statistical concepts in a manner that is easily understood by non-statisticians and provide adequate statistical justifications for actions/decisions/statements.
• Establishing and maintaining sound working relationships and effective communication with the Clinical Trial Team and Advanced Quantitative Sciences team.
• Overseeing all Biostatistics resources and work for assigned trials and/or related non-clinical activities, and ensuring work is timely and of adequate quality.

Minimum Requirements:

• PhD (in Statistics, Mathematics, Computational Sciences, Data Science, or equivalent)
• Proven knowledge and expertise in statistics and its application to clinical trials or public health
• Proficiency in statistical software packages (e.g. R)
• Ability to influence decisions that directly impact the assigned clinical trial and team ability to deliver objectives
• Good communication and presentation skills, ability to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives
• Proficiency in English (oral & written)

Nice to Have:

• Depending on your assignment, you it may be helpful to have expertise in one or more of the following areas: Bayesian statistics, causal inference, clinical trial design, data exploration, estimands, evidence synthesis, pharmacokinetics, machine learning, missing data, modelling approaches.

Skills Desired

Automation, Biostatistics, Clinical Trials, Computer Programming, Metadata Management, Statistical Analysis