The Senior Manager, Statistical Programming performs statistical programming and analysis oversight for OED (Oncology Early Development) clinical projects conducted by CROs. Oversees several compounds/indications on all statistical programming tasks delivered by CROs. Ensures data integrity and high-quality analysis from first in human through clinical proof of concept. Performs hands-on programming to validate analysis datasets and TLFs delivered by CROs and supports in-house studies for full set of analysis tasks. May manage regular or contract statistical programmers.
Responsibilities:
- Lead statistical programming activities for one or more compounds/indications or a therapeutic area.
- Manage a team of statistical programmers; plan resources for assigned projects.
- Ensure timely deliverables, quality processes, and consistency across projects.
- Develop and oversee SAS programs to create ADaM datasets following CDISC standards.
- Develop and oversee SAS programs to create Tables, Listings, and Figures.
- Ensure ADaM dataset consistency for individual studies and integrated data.
- Create documentation for regulatory filings (reviewer guides, data definition documents).
- Lead development of standard SAS macros and standard operating procedures.
- Manage, mentor, and create career development plans; participate in recruitment and selection.
Qualifications:
- MS in Statistics/Computer Science or related field with 9+ years relevant experience; OR BS with 11+ years.
- Minimum 2 years leading a team of statistical programmers.
- In-depth SAS programming knowledge for drug development.
- In-depth understanding of CDISC standards.
- In-depth understanding of drug development process, including regulatory filings experience.
- Clear oral and written communication; represent Statistical Programming Organization in cross-functional teams.
- Ability to estimate effort for project-related programming activities.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligibility to participate in long-term incentive programs.