Overview
Como parte de Consultoría de Parexel, cumplirá un rol vital al asistir a las empresas biofarmacéuticas y de dispositivos médicos a transitar el complejo y siempre cambiante entorno regulatorio. Respaldado por su experiencia científica, técnica y regulatoria, trabajará de cerca con los clientes para desarrollar e implementar estrategias regulatorias que colocarán sus medicamentos en el mercado con mayor rapidez y los mantendrán allí.
Valoramos la colaboración, la innovación y el aprendizaje continuo. Como miembro de nuestro equipo, se asociará con un grupo diverso de clientes y estará expuesto a diversos tipos de medicamentos y áreas terapéuticas. Asimismo, desarrollará sus habilidades a través de asignaciones desafiantes y con la mentoría de profesionales experimentados en asuntos regulatorios. Además, disfrutará de la flexibilidad de trabajar en modalidad remota, al tiempo que forma parte de un equipo colaborador y dinámico.
Perfil del éxito
¿Posee estas competencias sociales y rasgos interpersonales para tener éxito en Parexel?
- Comunicador
- Estratégico
- Constructor de relaciones
- Solucionador de problemas
- Orientado al detalle
- Impulsado por los resultados
Acerca de este rol
Key Accountabilities:
Project Execution
- Acting as support biostatistician or statistical programmer to interact with the study team and the sponsor
- Support in drafting statistical sections of protocols, performing sample size and power calculation for studies.
- Supporting in reviewing data management plans, data specifications, and other related study documents
- Supporting in developing statistical analysis plans
- Contributing to the preparation of specifications for analysis datasets
- Supporting in developing statistical programs to generate listings, tables and figures as outlined by a statistical analysis plan
- Performing QC of TLFs and other analysis datasets
- Providing statistical input to Clinical Study Reports
- To help ensure quality standards are adhered to on all projects and new methodologies and techniques are adequately assessed and implemented.
- To help foster thought leadership opportunities.
Skills:
- Ability to manage priorities to meet multiple and sometimes competing deadlines.
- Excellent scientific, business writing, and presentation skills with attention to detail.
- Exceptional communication skills, especially in the relaying of technical information and project concepts.
- Competent in written and spoken English
- SAS, R, SQL, and/or Python
Knowledge and Experience:
- 2-4 yrs of experience with familiarity in healthcare consulting or pharmaceutical organizations.
- Strong basis in fundamental statistical concepts and methods and familiarity with techniques such as development of predictive equations, survival analysis (including parametric methods), longitudinal data analysis, meta-analysis, mixed treatment comparison, and other hierarchical analysis techniques, etc.
- Familiarity with machine learning techniques and Bayesian statistics is a plus.
- Strong statistical programming skills with standard software.
- Strong communication (spoken and written) and problem-solving skills, and an ability to learn-quickly.
- Ability to communicate effectively, in non-technical terms, with project team members.
- Ability to work well in a team as well as independently and be able to take leadership role with regard to methodological elements in projects.
Education:
- Master or higher degrees in Public Health, Health Economics, Health Policy, Statistics, Biostatics, Mathematics, or other quantitative fields.
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