Data Scientist
SOCAR Research, located in Nyon, Switzerland, is a leading Functional Service Provider with more than 30 years’ experience in the provision of clinical research and technology services to the pharmaceutical, biotechnology and medical device industries. SOCAR is seeking to hire an experienced Data Scientist. The ideal candidate will have a strong understanding of clinical research databases and must be tech-savvy. You will also have an excellent understanding of database administration and have previous experience working in eClinical systems. You will be part of a young and dynamic multidisciplinary project research team and will work closely with clinical trial managers, medical directors and biostatisticians.
Your responsibilities will include:
- Design and develop eCRFs and eCRF completion guidelines and/or user guidance
- Configure the EDC system to the requirements of a specific trial
- Perform / oversee user acceptance testing, user training, database release activities
- Program edit checks and data queries
- Program status/metric reports
- Develop Data Management (DM) related documentation (e.g. DM plan, Data base (DB) validation plan, DB release forms…)
- Develop and implement data transfer agreements with third parties
- Provide support to end users
- Review DM Standard Operating Procedures
- Ensure study timelines are met and data quality conforms to high industry standards
- Lock, transfer and archive databases.
Profile required:
- Master’s degree in computer science, physics, mathematics or equivalent in experience
- At least two years of clinical database development experience
- Experience using Electronic Data Capture (EDC) system(s)
- Experience working with Oracle and clinical database application
- Knowledge of SQL, PL-SQL - SAS and CDISC is a plus
- Fluency in English (oral and written)
- Understanding of the clinical research environment and good knowledge of global regulatory requirements such as ICH GCP and CFR 21 part 11
- An analytical mindset with problem-solving skills
- Detail-oriented with excellent organizational and communication skills
Clinical Research Associate (CRA)
SOCAR Research, located in Nyon, Switzerland, is a leading Functional Service Provider with more than 30 years’ experience in the provision of clinical research and technology services to the pharmaceutical, biotechnology and medical device industries. SOCAR is seeking to hire an experienced Clinical Research Associate (CRA). You will be part of a young and dynamic multidisciplinary project research team. Part of your responsibilities will be to perform clinical monitoring (remote and onsite) for designated projects and the remainder of the time will be office-based and will be spent, amongst others, performing tasks in data management such as checking clinical data for completeness and medical consistency, in preparation for statistical analysis.
Your responsibilities will include:
- Perform (remote) site visits, write-up the visit reports, follow-up and resolve issues arising from these visits
- Perform source data/document verification (SDV) remotely and onsite
- Perform (remote) source data review
- Perform remote monitoring / site management activities
- Maintain the electronic Trial Master File (eTMF)
- Perform data management activities (e.g. tracking the completion of the eCRFs at the site and perform data cleaning activities)
- Limited travel to sites
Your Profile:
- Medical-related scientific degree (Bachelor, Master, PhD, Nursing qualifications or similar degrees and/or experience)
- A minimal of three years’ experience as a Clinical Research Associate (CRA)
- Strong working knowledge and understanding of ICH-GCP, Swiss and other international laws and regulations governing clinical trials
- Strong medical/clinical knowledge
- Excellent clinical trial monitoring skills with a high level of attention to detail and sound problem solving skills
- Excellent interpersonal communication skills (verbal and written)
- Ability to prioritise multiple tasks and achieve project timelines
- Computer skills (MS Office) and experience in eCRF systems, CTMS Systems, as well as eTMF Software
- Fluent English and German (written and spoken); French and Italian is a plus
- Show commitment to and perform consistently high quality work
Statistician
SOCAR Research, located in Nyon, Switzerland, is a leading Functional Service Provider with more than 30 years’ experience in the provision of clinical research and technology services to the pharmaceutical, biotechnology and medical device industries. SOCAR is seeking to hire an experienced Statistician. You will be part of a young and dynamic multidisciplinary project research team.
Your responsibilities will include:
- Participate in the development / writing of Statistical Analysis plans (SAP)
- Program analysis data sets, including data derivations and data mapping
- Provide statistical review/input on study protocols
- Perform the statistical analyses per the SAP
- Develop programs and generate Tables, Listings and Figures for trial or project specific reports and statistical analyses
- Participate in the writing of the statistical report
- Participate in the programming of edit checks, setting up the trial database using SQL code
- Perform sample size calculations
Your Profile:
- MSc in Statistical or Mathematics discipline with a minimal of 3 years practical experience as a Statistician/ SAS programmer
- Knowledge of statistics applied to clinical studies
- Knowledge of international standards (ICH, GCP, CDISC)
- Good knowledge of programming in SAS (at minimum SAS base, SAS macro); knowledge of SQL and PL/SQL code is a plus
- Excellent interpersonal communication skills (verbal and written)
- Knowledge of statistical concepts in clinical trials (e.g. descriptive statistics, hypothesis testing, time to first event analysis etc.)
- Understanding of CDISC data models, especially SDTM and ADaM
- Ability to analyse problems and formulate ideas in a structured and logical manner
- Fluent in English (verbal and written)
- Show commitment to and perform consistently high quality work
If you possess a valid Swiss work permit and fit the profile required for this versatile and challenging position, please forward your application to
info@socar.ch - we look forward to talking to you. We will only respond to candidates who fit the profile for this position.
SOCAR is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.
Only direct applications will be considered for this vacancy. We do not accept speculative CVs or candidate profiles.