Join Our Mission to Improve Lives Worldwide
The Senior Biostatistician will support preclinical research, clinical development and medical investigation through statistical planning and analysis of clinical trials and other research studies, clinical database management and analytics.
The Impact You'll Make
Develop biostatistics and analytics competencies and resources;
Interpret statistical results;
Support study design and statistical empowerment of research and pre-clinical, clinical, and post-market studies;
Provide or support sample size calculations for experimental design of clinical studies;
Prepare or critically review statistical sections of clinical study protocols, case report forms (CRFs), data review guidelines, data management plans, data transfer agreements, TLFs and clinical study reports (CSRs);
Develop statistical analysis plans (SAP) in accordance with the protocols and guidelines aligned with regulatory strategy;
Support quality control of analysis and monitor clinical data when appropriate;
Support biostats regulatory (FDA, EMA, etc.) requirements and questions;
Validate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS;
Serve as the primary liaison between the Clinical Research team and external Biostatistics consultants, facilitating communication and ensuring alignment on project goals and statistical methodologies;
Translate medical questions into statistically testable hypotheses or further analytics;
Write statistical sections in reports and scientific publications;
Provide statistical support for post hoc or exploratory analyses for regulatory agencies or any other internal (Medical Affairs, Regulatory Affairs) and external ad-hoc requests;
Communicate results to non-statistically expert collaborators;
Contribute to the evaluation of IIS proposals;
Collaborate effectively with other departments, teams and colleagues as required, to support overall company objectives.
What You'll Bring
Advanced degree (MS/PhD or equivalent) in Statistics, Biostatistics or related field;
At least 5 years of pharmaceutical industry experience;
Experience in Neurology or Rare Diseases areas is a plus;
Proven track record for conducting and reporting statistical analysis to support clinical studies and medical research;
Knowledge with complex statistical methods that apply to Phase I-IV clinical trials;
Knowledge and experience in SAS and R/Python programming;
Experience with statistical analysis that will be used in (and aligned with) regulatory package for marketing authorization application;
Strong drive and determination to achieve results, high degree of autonomy, organization skills, experience on methodology identification and application for statistical data analysis;
Familiarity with CDISC and SDTM standards and harmonization;
Understanding of different phases for clinical development and their main objectives;
Excellent communication and presentation skills;
Good team player, eager and willing to learn with solid interpersonal relationship skills.
#J-18808-Ljbffr
