OPPORTUNITA' DI LAVORO

Offerte

Le inserzioni verranno pubblicate gratuitamente per un periodo di tre mesi.

Senior Statistician

International CRO located in Desio (MB) for expanding its staff in the Biometrics Department, research:

Senior Statistician

Job Type: Permanent, Full-time

We are looking for a Senior Statistician able to work independently on all statistical tasks related to the assigned clinical trials.

The main responsibilities include:
• Providing statistical input to the study design
• Sample size estimation
• Review of Case Report Form
• Definition of protocol deviations and edit checks.
• Writing/review of Statistical Analysis Plans.
• Development/validation of SAS programs for the statistical analysis of clinical trial data. Generation of datasets/tables/ figures /listings for Clinical Study Reports and/or publications.
• Writing/review of statistical sections of Clinical Study Reports.
• Providing consultancy on statistical methodology.
• Interacting with Health Authorities (e.g. Ethics Committees), Steering/Data Monitoring Committees and external consultants as appropriate.
• Collaboration in establishing and maintaining document/programming standards.

Job Requirements

• Degree in Statistics with at least 3 years of experience in drug development process.
• Solid knowledge of HA guidelines and statistical methods for analyzing clinical data
• Excellent knowledge of SAS programming
• Fluency in English
• Very good communication and presentation skills
• Strong interpersonal skills and team work.
• Strong planning and organisational skills

If interested please send the CV to the e-mail address: Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.

We will not reply to applications that do not meet the required profile

Senior SAS programmer

International CRO located in Desio (MB) for expanding its staff in the Biometrics Department, research:

Senior SAS programmer

Job Type: Permanent, Full-time

We are looking for a Senior SAS Programmer able to work independently on all SAS programming activities related to the assigned clinical trials.

The main responsibilities include:
• Develop SAS programs for generating datasets, tables, figures and listings for clinical trials (according to ICH E3) and/or publication and/or Health Authorities requests
• Generate CDISC compliant datasets (SDTM/ADaM) and related documentation
• Develop standard SAS macros and prepare the corresponding validation documents
• Develop SAS programs/macros and utilities for data management
• Establish and implement programming rules
• Collaborate in establishing and maintaining SOPs related to SAS programming
• Collaborate in establishing and maintaining document/programming standards.

Job Requirements

• At least 3 years of experience in a Pharmaceutical company or CRO.
• Proven knowledge of SAS
• Proven knowledge of CDISC and experience in developing CDISC standard specifications and datasets (SDTM, ADaM)
• Knowledge of other statistical software packages
• Knowledge of statistics and its applications to clinical trials.
• Analytical approach and effective problem-solving skills; ability to manage multiple activities
• Ability to work independently
• Strong interpersonal skills. Good team player

If interested please send the CV to the e-mail address: Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.

We will not reply to applications that do not meet the required profile

Senior Data Manager

International CRO located in Desio (MB) for expanding its staff in the Biometrics Department, research:

Senior Data Manager

Job Type: Permanent, Full-time

We are looking for a Senior Data Manager, able to work independently on all data management tasks related to the assigned clinical trials.

The main responsibilities include:
• Design paper or electronic Case Report Forms (CRF), including paper PROs (diaries, questionnaires)
• Prepare/review data management documents
• Set-up and validate eCRF/clinical database and related tools
• Coordinate/perform data cleaning activities
• Perform coding activities of medications and medical terms using medical dictionaries
• Perform SAE reconciliation, import and reconciliation of external clinical data
• Liaise with Sponsor and third parties with regard to data management activities
• Track activities and milestones to ensure timely deliverables
• Collaborate in establishing and maintaining SOPs related to Data Management
• Collaborate in establishing and maintaining document/programming standards.

Job Requirements

• Scientific degree with at least 5 years of experience in a Pharmaceutical company or CRO
• Proven expertise in clinical data management.
• Solid knowledge on relational databases and programming languages like SQL. Knowledge of SAS system (Base, ODS).
• Experience in developing CDISC standard specifications
• Solid knowledge of HA requirements that pertain to pharmaceutical research and specifically to Data Management
• Fluency in English
• Good communication skills and team work
• Strong planning and organisational skills

If interested please send the CV to the e-mail address: Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.

We will not reply to applications that do not meet the required profile

Head of Data Management Unit

International CRO located in Desio (MB) for expanding its staff in the Biometrics Department, research:

Head of Data Management Unit

Job Type: Permanent, Full-time

We are looking for a suitable candidate to head our Data Management Unit and lead a team of data managers and programmers to:
• Plan and supervise the activities of the Data Management group in order to ensure timely and high quality deliverables
• Ensure processes are correctly applied within the Data Management group
• Liaise with Sponsor and third parties with regard to data management activities
• Collaborate with the ICT Dept. on the EDC system and related tools
• Define the timeframes and costs of each project
• Establish and maintain SOPs related to Data Management
• Establish and maintain document/programming standards.

Job Requirements:

• At least Master Degree in Statistics (or equivalent degree) with 10 years of experience in clinical data management
• Solid knowledge and experience in drug development process and HA guidelines
• Solid knowledge on relational databases and programming languages like SQL. Knowledge of SAS system (Base, ODS)
• Experience in developing CDISC standard specifications and datasets (SDTM, ADaM)
• Fluency in English (oral and written)
• Strong planning and organisational skills
• Very good communication and presentation skills
• Quality and detail oriented with high standards
• Good leadership skills. Ability to give effective guidance to Data Managers and SAS Programmers.

If interested please send the CV to the e-mail address: Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.

We will not reply to applications that do not meet the required profile

Richieste

Tutti coloro che fossero interessati ad inserire il proprio CV in questa pagina, sono invitati ad inviarlo in formato word con la relativa autorizzazione alla pubblicazione sul sito alla Segreteria SSFA (info@ssfa.it)
Questo servizio è fornito gratuitamente da SSFA a tutti.

Opportunità di lavoro

logo-ssfa