Sito dei Biostatistici Italiani

Offerte di Lavoro


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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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