Statistical Programmer II
CLINIPACE
Spain
hace 3 días

Job Overview :

The Statistical Programmer II is responsible for programming activities for the data preparation and analysis of clinical data with medium to high complexity.

Duties include the creation of datasets, tables, listings and figures according to the project specifications as well as coordination of Quality Control efforts and implementing all programming required for study / project completion.

Job Duties and Responsibilities :

Development and documentation of programs used in the production of computer-generated outputs for clinical study reports, registration and submission documents, publication requirements plus any other document used to present clinical trials data, e.

g. answers to requests from health authorities, individual sponsors requests, scientific papers and conferences, etc. in line with existing regulatory guidelines, industry standards and standard operating procedures issued by Clinipace and / or clients as appropriate.

Conception and generation of dataset specifications

Design of integrated databases and development of mapping specifications for integrated datasets

Development and documentation of programs used to generate datasets

Development and documentation of programs used to generate listings, tables and graphs

Program validation including generation of validation documentation

Data preparation and documentation according to CDISC data standards

Preparation of electronic submission of clinical data

Intense and cross functional interaction with other members of the project team

Providing internal consultancy in various review activities like database design, data validation rules, analysis plans, table shells etc.

Interaction with clients

Design, development, documentation and validation of tools and macros to continuously improve quality and efficiency of processes applied

Writing of User Manuals

Training of group members on new processes, programs etc. as appropriate

Initial Training on existing processes, programs etc. for new group members

Attending and representing the company at business conferences

Coordination of allocated teams of Statistical Programmers assigned to a specific client project including the monitoring of workload, estimation and forecast of resource needs within the specific activity and responsibility for coaching and education of other team members .

Supervisory Responsibilities :

Job Requirements :
  • Education
  • Education
  • BSc, MSc or equivalent experience in information technology, mathematics, statistics or medical documentation

  • Experience
  • Minimum of 4 years’ experience in processing and analyzing clinical trial data or demonstrated aptitude for statistical programming work

    3 years’ practical experience in the use of a statistical software package (like SAS or R) with respect to all aspects of software development and validation

  • Skills / Competencies
  • Highly developed analytical skills, team player qualities (knowledge, skills, personal qualities)

    Fluency in English

    Sound knowledge of the SAS programming language

    Knowledge of relevant regulatory requirements

    Knowledge of medical terminology and conduct and analysis of clinical trials

    Knowledge of industry data standards (e.g. CDISC SDTM and ADaM)

  • Capabilities Team player : Shows support for teamwork, cooperation, self-control, and flexibility to get the job done.
  • Comfortable working under supervision and as part of a team. Practices professionalism and integrity in all actions. Demonstrates honesty, trust and fairness.

    Strong written and verbal communication skills

    The company will not accept unsolicited resumes from third party vendors.

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