Remote Senior Statistical Programming Lead
Otsuka America Pharmaceutical Inc.
A complete application in a minute
Tailored resume and cover letter, ready to send.
Benefits offered by this job
Job summary
Otsuka America Pharmaceutical Inc. is seeking a Senior Manager, Statistical Programming to lead development and validation of TFLs for clinical trials.
The role emphasizes collaboration within the Statistical Programming team, cross-functional teams, and external vendors to ensure data integrity and regulatory compliance. The position involves leading programming strategies, quality reviews, AI-enabled approaches, and submission support, with a focus on SDTM/ADaM and regulatory deliverables in a
Qualifications
- Proficiency in SAS, R and AI-enabled programming tools for TFLs
- Knowledge of CDISC standards and data structures
- Experience with ADaM/SDTM, define.xml and regulatory deliverables
- Ability to develop programming strategies and standards
- Experience with AI-enabled programming in regulated environments
- Master's degree with 4+ years in pharma is preferred
Responsibilities
- Lead end-to-end statistical programming activities for TFLs
- Develop and validate datasets and listings for trials
- Review and align planning documents with programming deliverables
- Support submission preparations and regulatory responses
- Interact with vendors on standards and AI-enabled workflows
- Lead process improvements and automation initiatives
- Supervise contract workers and guide programming practices
Skills
Education
Tools
Job description
Otsuka America Pharmaceutical Inc. is seeking a Senior Manager, Statistical Programming to lead development and validation of TFLs for clinical trials.
The role emphasizes collaboration within the Statistical Programming team, cross-functional teams, and external vendors to ensure data integrity and regulatory compliance. The position involves leading programming strategies, quality reviews, AI-enabled approaches, and submission support, with a focus on SDTM/ADaM and regulatory deliverables in a
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
