Sito dei Biostatistici Italiani

Offerte di Lavoro

Janssen Research & Development LLC, a Johnson & Johnson company, is recruiting for an Associate Director, Advanced Insights – Integrated Clinical Operation Analytics. This position can be based in Spring House, PA; Imperia, Italy; Beerse, Belgium; or High Wycombe, United Kingdom and will require 5% domestic and international travel.

This role will be responsible for translating analytics and generating insights from data with high level of autonomy. The incumbent will lead and manage data science projects developed by Integrated Clinical Operation Analytics (ICOA) group. This role is also responsible to ensure that he/she provides strategic input into analytics projects.

This role will lead initiatives as an individual contributor and provides input on hiring talent for ICOA and EBIS group where required. The individual will have proven ability leading multiple projects in a matrix environment. The job holder shall have technical expertise in data science and analytics space generating insights from data and providing solutions to the business as needed.

Principal Responsibilities:

  • Lead and execute clinical and operation advanced analytics that facilitates gaining deep insight to clinical and operation data for relevant business partners in Global Development (GD) and clinical therapeutic areas.
  • Develop novel data science methodologies to generate deep insights from disparate data sources.
  • Provide subject matter expertise to teams in identification and application of the right data science methodology for a business problem.
  • Formulate the right business problem in collaboration with business and create necessary analysis plans.
  • Develop machine learning methodologies both supervised and unsupervised as appropriate to the business problem.
  • Develop scalable and robust code in R or Python in support of data science projects.
  • Ensure the life cycle management of the models is maintained through code repositories and version control tools.
  • Perform data engineering, data preprocessing and data wrangling activities utilizing different approaches such as SQL, NOSQL, graph models.
  • Contribute to long term strategy, overseeing the development, monitoring and reporting on successful execution of annual goals and objectives of Advanced Insights group in line with EBIS, GCDO and Development Management, Operations and Analytics (DMOA) imperatives
  • Establishing an internal and external benchmarking network facilitating the distillation of best data integration and analytics practice from leading organization externally while also identifying best practice from internal teams within J&J.
  • Mentor and coach junior level staff.

Education and Experience Requirements:

  • This Individual should have a minimum of 7 years with relevant master’s degree in data science, statistics, Informatics, operations research, computer science, engineering or information systems or a related discipline
  • OR A minimum of 3 years with a Ph.D. degree in data science, statistics, Informatics, operations research, computer science, engineering or information systems.

Candidature 

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Chiesi Farmaceutici ha aperto le selezioni per Head of Statistics all’interno del Dipartimento di Statistica del Global Clinical Development (R&D)

Job Responsibilities:

  • To provide statistical leadership within the clinical statistics department and R&D organization
  • Be accountable for statistical strategy, clinical development plans and regulatory submissions
  • To provide statistical methodology and technical guidance, ensuring statisticians have the necessary competencies to carry out their duties
  • To promote statistical expertise to optimize R&D activities, foster implementation of innovative methods and processes
  • Expected to effectively manage the statistical team to ensure planned activities and deliverables are adequately resourced and agreed milestones met
  • Building and maintaining effective strategic working relationships with internal and external partners, with industry, academic, professional and other organizations
  • Ensure GCP compliance and support the creation / review and approval of SOPs, as needed

 Education: Master degree or PhD in Statistics.

 Professional Experience:

  • Significant experience in managing complex projects and strong experience with submission and regulatory interactions for at least 10 years (CROs or Pharmaceutical Companies)
  • At least 5 years staff management experience. Candidates without a previous experience of staff management might be considered, based on technical skills and previous experience in managing complex projects

Technical capabilities:

  • Strong experience in clinical drug development
  • Strong statistical methodology expertise
  • Track record of statistical contributions in clinical drug development, with a broad knowledge of all phases of drug development (Phase I-IV)
  • Strong experience of regulatory interactions and submissions in Europe and US
  • Examples of applying innovative statistical thinking.

Skills

  • Strong skills in developing people and teams, coaching skills
  • Excellent communication skills, demonstrated ability building and maintaining strong working relationships
  • Demonstrated ability to lead and make major contributions to department, organizational and/or industry-wide initiatives, through effective communication and influence.
  • Strong time management skills; able to effectively organise and manage a variety of activities
  • Highly motivated to drive innovation

 Languages

Proficiency in both written and spoken English is a must.

Job Location: partially home-based, Parma (Italy).

Sottomettere la propria candidatura tramite il sito dell’azienda: https://www.chiesi.com/opportunita-di-lavoro-italia/

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Experisper conto di un’importante azienda farmaceutica, è alla ricerca di un Head of Biostatistics 

Attività: 

La figura sarà Responsabile della supervisione della strategia statistica e degli obiettivi correlati allo sviluppo clinico.
• Gestire il team per garantire adeguate approvazioni statistiche per la progettazione e l’organizzazione di studi clinici / non clinici;
• Fornire pensiero strategico per supportare le decisioni e guidare la strategia di sviluppo; • Supervisionare la collaborazione con la farmacovigilanza nell’analisi dei dati di sicurezza;
• Concepire e scrivere sezioni SAP e metodi statistici per protocolli di sperimentazione clinica e ricerca;
• Preparare report statistici, tabulazioni e grafici per la presentazione durante le riunioni.

Requisiti: 

• Laurea specialistica in biostatistica, statistica o settore correlato;
• Competenza nella programmazione SAS;
• Inglese: Fluente

Sede di lavoro: Pomezia e / Bologna
Se interessati contattare antonella.caldarola@it

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Pharma Point, per conto di Angelini Pharma, è alla ricerca di una risorsa da inserire all’interno della funzione Biometry col ruolo di CLINICAL DATA MANAGER  

La principali attività di cui la risorsa sarà responsabile sono:

  • fornire l’input nel protocollo di studio relativamente agli aspetti di Data Management;
  • preparare/revisionare la CRF (Case Report Form);
  • preparare/revisionare il Data Management Plan e Data Validation Plan;
  • progettare, sviluppare e convalidare la eCRF;
  • manutenere il database e gestire le discrepanze;
  • effettuare la riconciliazione degli eventi avversi seri in collaborazione con la Pharmacovigilance;
  • effettuare/revisionare l’attività di codifica dei dati;
  • preparare le linee guida per la compilazione della CRF/eCRF;
  • preparare ed effettuare le sessioni di training;
  • redigere/revisionare SOPs;
  • rappresentare il punto di contatto, per le attività di data management, sia interno che esterno (sedi sperimentali, CRO, etc.).

I requisiti richiesti sono:

  • laurea in discipline scientifiche (scienze statistiche, biologia, informatica, matematica, farmacia, CTF);
  • esperienza pregressa di almeno 3 anni nel ruolo o in posizioni analoghe in ambito farmaceutico o equivalente;
  • buona conoscenza del sistema SAS/STAT;
  • buona conoscenza della lingua inglese;
  • buona conoscenza del pacchetto MS Office

Luogo di lavoro: Roma, Italy.

Tipologia di contratto offerto: tempo indeterminato.

Inviare le candidature a v.grimaldi@pharmapoint.it