Clinovo
Location
Secunderabad | India
Job description
Company Description
Clinovo is an ISO certified global service partner for pharmaceutical, biotechnology and medical devices companies. We specialize in delivering excellence on the clinical development value chain to improve the quality of life for patients worldwide. Our services include biostatistics & programming, clinical data management, clinical operations, medical writing, pharmacovigilance, and drug regulatory operations. Clinovo also offers customized functional services, outsourcing, and flexible business engagement models.
Role Description
• 6-8+ yrs of statistical programming (production/validation) experience using base sas, advanced sas in CRO/Pharma space
• Min 6 years in CDISC SDTM, ADaM and
TLFs programming
• Experienced with developing mapping
specifications for SDTM and ADaM
• Experienced with ISS/ISE mapping and
submissions is a plus
• Expertise with developing macros as
needed for SDTM, ADaM and TLF programming
• Thorough knowledge and working
experience in SDTM (V3.2, 3.3, 3.4) and ADaM (V1.1, 1.2) Implementation guides,
controlled terminology, Pinnacle 21 validation
• Excellent communications skills
• Experienced with developing submission
components such as aCRF, define.xml, cSDRG, ADRG
Job tags
Salary
