US-NJ, Senior Principal Biostatistician 216529BR-MZ
Senior Principal Biostatistician
Global Drug Development
East Hanover, NJ
Research & Development
The Senior Principal Biostatistician is responsible and accountable for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team. Works independently at the trial level and may lead indication or project level statistical activities for a development project under limited supervision.
Proposes and leads implementation of modern and innovative trial/experimental designs, statistical models, analysis and data exploration methodologies at the study or project level.
1. Study level:
a. Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, 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.
b. 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.
c. Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate.
d. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings.
e. 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 assigned trials.
f. 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.
g. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team.
h. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities.
2. Project level:
a. May be a core member of an early project team for a low-complexity program and represents Biostatistics and Pharmacometrics as part of development plan with oversight.
b. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight.
c. Collaborate cross-functionally (e.g. data management, programming, medi-cal writing) to ensure timeliness and quality of statistical deliverables.
d. Propose and implement innovative designs and methods to optimize dose finding and drug development.
e. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors.
f. Significantly contributes to project team preparation for HA Advisory Committees and meetings.
3. Franchise or Global Line Function level: Significantly contribute to initiatives at global line function level
4. Enterprise level:
a. Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives.
b. Contribute to the review and implementation of health authority guidance.
c. Identify, evaluate, and promote the use and the acceptance within and out-side the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings.
5. External level:
a. Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate.
b. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings.
6. People Management: Mentor new hires and/or junior Statisticians
Impact on the organization:
1. High impact by leading the statistical scientific activities: planning, evaluation, risk mitigation, health authority acceptability for trials and indications.
2. Timely delivery of high quality statistical deliverables to meet the needs of the clinical trial team.
3. Acceptability of clinical study report and documentation by Health Authorities including exploratory trial level deliverables.
4. Efficient design, analyses, and reporting leading to quality decisions and submissions, and reduced time and costs for development and registration.
5. Ensuring quality reputation of Novartis with Health Authorities and other external partners.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Education (desirable): MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 3+ years relevant work experience
Languages: Fluent English (oral and written)
Good communication and presentation skills.
Requirement: 1. Influences decisions that directly impact the trial/project and team ability to deliver objectives.
2. 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 clinical trials; able 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 effectiveness working on a multidisciplinary team to achieve team objectives.
3. Good understanding of Franchise/Therapeutic Area and or regulatory activities.
4. Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions.
5. Good business ethics.
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