Senior Manager, Clinical & Statistical Programming
New
U
Umoja BiopharmaBiopharma clinical trials
We are open to remote within the US for the right candidate.Full-TimeManager
Salary170,000 - 210,000 USD per year
Apply NowOpens the employer's application page
Job Details
- Experience
- A minimum of 8+ years of experience in pharmaceutical companies or CROs is required
- Required Skills
- GCPR
Requirements
- Bachelor’s degree in biostatistics, statistics, computer science, or a closely related field.
- At least 8 years of experience in pharmaceutical companies or CROs.
- Clinical programming proficiency and experience with quantitative analysis methodologies.
- Advanced SAS programming expertise.
- Substantial knowledge of CDISC standards.
- Extensive experience preparing regulatory submission packages.
- Demonstrated leadership experience managing projects and guiding cross-functional teams.
- Working knowledge of ICH, FDA, and GCP regulations and guidelines.
- Ability to travel up to 10% as needed if working remotely.
- A master’s degree is preferred.
- NDA/BLA submission experience, regulatory agency interaction, and experience leading early- and late-phase clinical trials are preferred.
- Experience in immunology, hematology, or oncology clinical trials and experience using R in clinical analysis are preferred.
Responsibilities
- Perform clinical and statistical programming activities for clinical trials throughout the full study life cycle.
- Review clinical trial protocols, SAPs, CRF designs, and EDC deployments, and provide input for EDC edit checks.
- Guide and review CRO outputs, including submission datasets, programs, specifications, TLFs, define.xml, and reviewer guides.
- Execute and support programming activities for IND, NDA, and/or BLA regulatory submissions.
- Review data management plans and data transfer plans, and test EDC deployments for downstream programming readiness.
- Provide hands-on SAS programming for safety and efficacy analyses, exploratory analyses, and publication analyses.
- Provide technical oversight to statistical and data programmers and contractors as needed.
- Collaborate with biostatistics, data management, clinical operations, study physicians, and safety review teams to address data and programming issues.
- Support audits, inspections, and regulatory inquiries related to statistical programming deliverables.
- Help build biometrics infrastructure, including macros, programs, TLF shells, SOPs, and programming and data traceability practices.
View Full Description & ApplyYou'll be redirected to the employer's site
