Philadelphia, Pennsylvania, United States Hybrid / WFH Options
Jazz Pharmaceuticals
practices, procedures, and methodologies Thorough understanding of clinical trial design and reporting process, as well as regulatory reporting requirements, including electronic data submissions and CDISC implementation Excellent SAS programming skills and willingness to lead the implementation of new software (i.e., R, Python) Must be highly motivated and able to work more »
equivalent in computer science, mathematics, statistics, life sciences or related field(s). Excellent SAS programming skills (BASE, MACRO, GRAPH). Excellent knowledge of CDISC standards. Statistical Programming experience within a CRO Pharmaceutical/Healthcare/Biotechnology industries. Experience in statistical programming initiatives, and development of processes. Knowledge and experience more »
or CRO industry working ICH/GCP guidelines. Experience in both paper and electronic TMF, and familiarity with naming and filing conventions and the CDISC TMF Reference Model and applicable industry guidelines Experience in QC, maintenance of trial tracking sheets and databases and of preparing documentation for archiving. Proven ability more »
the types of risks associated with a study and the impact on key parameters, such as study timelines. Advanced knowledge of data structures (e.g., CDISC SDTM, ADaM), software development lifecycle and their implementation. Experience with ISS/ISE and submissions. What you will receive: Work for an award-winning global more »
Statistical Programmer - multiple levels Home based #Oncology focused Our client, a global mid-size Pharma, have extended reputation in key therapeutic indications e.g. oncology, rheumatology, rare diseases, etc. and has supported the development of some of the most successful products. more »
Palo Alto, California, United States Hybrid / WFH Options
Jazz Pharmaceuticals
regulatory requirements and guidelines, e.g., ICH Guidelines and drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC SDTM and ADaM standards. Able to work in a fast-paced, flexible, team-oriented environment. Possess excellent interpersonal and communication skills (written and verbal). … Experience in contributing to IND submissions and defense is required. Experience with NDA or BLA submissions preferred. Proficient SAS programming skills, solid understanding of CDISC models and standards. Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills. Description of Physical Demands Occasional mobility within office environment. Routinely more »
Programming experience within the pharmaceutical industry essential. Excellent knowledge of SAS essential and R or Python advantageous. Good working knowledge of data structures e.g. CDISC, SDTM, ADaM, Comprehension of clinicaldatastandards (CDISC), TLFs, and submission guidelines Exposure to working with clinical datasets, statistical methodology, and CSR/submission deliverables. more »
