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Location: 

Haifa, IL, 3508504

Description: 

Clinical Trials Programmer Analyst 

 

Novocure, a medical device company developing breakthrough theology for cancer treatment. We are looking for a Clinical Trials Programmer and Analyst who is responsible for all activities related to data management on all assigned clinical trials from the preparation of the study until archiving.

 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Create SAS programs to check the integrity of the clinical data
  • Performing routine quality checks using SAS programs of the data recorded for clinical trials patient’s data in line with Novocure quality standards
  • Performing data quality control and quality of SAS software codes before annual reports and DMC meeting.
  • Providing input and development of the study related documents such as: study execution plans (including Data Management Plan), eCRF design and Edit Checks specifications, eCRF completion guidelines, data reconciliation plans, SAS Listings Specifications, critical data review plan, Statistical Analysis Plans (SAPs), and other as required
  • Proactive identification and assisting in solution of issues related to data on assigned trials.
  • Collaborating with clinical operation and safety team members to support the maintenance of study reports
  • Creating and validation of data tabulations,analysis data and Tables, Listings, Graphs for submission to the regulatory authority. 
  • Other responsibilities as assigned

 

QUALIFICATIONS/KNOWLEDGE:

  • Qualifications:
  • Bachelor’s Degree, in life sciences, computer science, pharmacy, statistic or nursing or equivalent relevant degree

 

  • Knowledge:
  • 2 years of experience in a pharmaceutical, biotechnology, CRO or related environment
  • Programming experience in SAS skills required with around 2 years of experience in statistical programming with emphasis on data management and statistical programming in various phases of clinical trials.
  • Work experience in creating SDTM, ADAM datasets following CDISC standards for regulatory submissions.
  • Experienced in generating and validation of Tables, Listings, Graphs. 
  • Experience in Phase I-III clinical trials
  • Knowledge of ICH GCP, CFR, CDISC and other relevant regulations and guidelines
  • Accredited GCP course desirable
  • Fluency in English (verbal and written) and excellent communication skills
  •  Basic Statistical analysis skills preferred.
  • The candidate must be responsible, detail-oriented, and creative with excellent organizational skills.
  • Advanced computer skills, and strong oral and written communication skills.
  • SQL and R programming is an advantage. 
  • Experience in development of EDC system is an advantage.
  • Ability to work in a fast-paced collaborative environment and prioritize multiple tasks. Should also be capable of working both independently and collaboratively.
  • Strong critical thinking and problem-solving skills
  • Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines
  • Excellent organizational and record-keeping skills
  • Flexibility in work hours and readiness to travel abroad on a routine basis

 

#We are working on a Hybrid model

 

ABOUT NOVOCURE:

Our vision

Patient-forward: aspiring to make a difference in cancer.

Our patient-forward mission

Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

Our patient-forward values

– innovation

– focus

– drive

– courage

– trust

– empathy

 

#IL-GK1