Lead Statistical Programmer- CDI -M/F
Core
Lead Statistical Programmer designing and executing programming for Randomized Controlled Trials (RCTs) and Real-World Evidence (RWE) studies in pharmaceutical dermo-cosmetics.
Role type
Senior IC Statistical Programmer (CDISC/RCTs)
Builds
Production statistical analysis datasets and regulatory submission packages for clinical trials
Domain
Pharmaceutical clinical trials / Biometry
Deliverable
production ML models | product features | dashboards & analysis
Required skills
SAS programming, R programming, CDISC SDTM, CDISC ADaM, Define.xml, ADRG, RCT study design, RWE study design, regulatory guidelines (ICH/EMA/FDA/PMDA)
Preferred skills
Python, SQL, oncology clinical trials, EMA/FDA/PMDA submission experience
Technologies
SAS, R, Python, SQL
Responsibilities
Develop and validate programs for data analysis and reporting in accordance with regulatory guidelines; Collaborate with statisticians and data managers for accurate data processing; Assist in selection and evaluation of subcontractors; Contribute to preparation of regulatory documents and scientific publications; Ensure biometry documentation is included in the electronic Trial Master File (eTMF)
Seniority
Senior, hands-on IC