The Principal 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.
1. Study level:
a. 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.
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. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings.
d. 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.
e. 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.
f. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team.
g. 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.
a. Contribute to project level activities as needed.
b. Contributes to project team preparation for HA Advisory Committees and meetings.
3. Franchise or Global Line Function level: Contribute to initiatives at global line function level
4. Enterprise level:
a. Participate in non-clinical project activities as needed
b. Contribute to the review and implementation of health authority guidance
c. Promote the use and the acceptance of innovative methods within the organization, through scientific collaborations
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.
MS (in Statistics or equivalent) with 4+ years relevant work experience or PhD (in Statistics or equivalent)
1. Influences decisions that directly impact the assigned clinical trial and team ability to deliver objectives.
2. Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modeling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills.
3. Proficiency in use of statistical software packages (e.g. SAS, R).
4. Knowledge of drug development and Health Authority guidelines.
5. Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives
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