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Skills: Biostatistics, Clinical Trials, SAS Programming, CDISC ADaM, Statistical Analysis
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Full-time
postgraduate degree
Posted 12d ago
~40 hrs/week
Responsibilities
Lead biostatistics activities for clinical trials, including protocol development, statistical analysis plans, and SAS programming. Collaborate with project teams, clients, and vendors to ensure high-quality statistical deliverables and regulatory compliance.
Requirements
Requires an MSc in Statistics or equivalent with expert knowledge of clinical research statistical principles and SAS programming. Candidates must possess strong experience with CDISC ADaM standards and relevant regulatory guidelines like FDA and EMA.
Full job description
Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Job Description
In this role, you will:
Lead all biostatistics activities related to clinical trials as responsible project statistician
Communicate with project teams, clients and vendors on statistical questions
Develop and review statistical sections of protocols, including sample size calculations
Develop statistical analysis plans
Develop and document analysis database structures (i.e. SAS analysis data set structures)
Develop SAS program requirements and specifications
SAS programming and program validation
Review and QC of statistical deliverables (tables, listings, figures, etc.)
Perform statistical analysis and report results
Consult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products
Liaise with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics
Participate in bid defense meetings and kick-off meetings
Train statisticians and SAS programmers
Prepare and deliver presentations at investigators' meetings
Address audits findings/recommendations, and follow-up on and resolution of audit findings
Qualifications
MSc in Statistics or equivalent
Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
Ability to apply a range of advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information
Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
Expert knowledge and understanding of the SAS programming
Expert knowledge and understanding of CDISC ADaM standard
Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
Ability to work in English
Please submit your CV in English.
Additional Information
Our mission is to be the best CRO in the world as measured by our employees, clients, sites, and vendors. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way.
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
http://www.psi-cro.com
Offices: Baarerstrasse 113a, Zug, 6300, CH
Number One Patient Enrollment CROClinical ResearchClinical TrialsOncologyHematologyMultiple SclerosisInfectious DiseasesPatient EnrollmentPhase 2 Phase 3
How many Data & Analytics jobs are open in Prague, Czechia right now?
There are currently 443 open data & analytics positions in Prague, Czechia listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Data & Analytics roles in Prague, Czechia?
Companies currently hiring include PwC, Deutsche Börse, PwC Central and Eastern Europe, SentinelOne, REVEL, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Data & Analytics jobs in Prague, Czechia?
Yes — 306 of the 443 open data & analytics positions offer remote or hybrid work (34 remote, 272 hybrid).
How do I apply for Data & Analytics jobs in Prague, Czechia?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.