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Senior Manager, Statistical Programming
AmgenSenior Manager in Statistical Programming ensuring accuracy in clinical activities at Amgen. Leading global study deliverables and mentoring staff for Rare Disease and therapeutic area products.
Tech Stack
Tools & technologiesSDLCSQL
About the role
Key responsibilities & impact- Ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate
- Lead a group of Rare Disease and/or other therapeutic area products
- Accountable and responsible for Global Statistical Programming study results and submission activities for the assigned product areas
- Set and drive forward the programming strategies such as functional standards and industry requirements for the assigned product areas globally
- Plan and monitor progress of projects and address issues accordingly
- Support GSP Functional Service Provider (FSP) relationship and oversight
- Ensure the product goals can be met via the FSP staff
- Provide GSP product level input to developing and managing resource plans and budgets for GSP
- Efficiently and effectively monitor and utilize assigned staff at product level according to priorities
- Lead and/or participate in departmental process improvement initiatives and cross-functional working groups
- Assist in study and system audits and inspections by internal and external bodies
- Develop, review, and implement Policies, SOPs and other controlled documents affecting GSP globally
- Provide hands-on support to the assigned product areas as required
- Provide coaching and mentoring to staff
- Provide input into career development plans for all staff on assigned projects.
Requirements
What you’ll need- Doctorate degree and 2 years of statistical programming in Pharmaceutical industry experience OR Master’s degree and 6 years of statistical programming in Pharmaceutical industry experience OR Bachelor’s degree and 8 years of statistical programming in Pharmaceutical industry experience OR Associate’s degree and 10 years of statistical programming in Pharmaceutical industry experience OR High school diploma / GED and 12 years of statistical programming in Pharmaceutical industry experience
- In depth knowledge of SAS Graph, SAS STAT, SAS Macro and SQL
- Advanced SAS analysis and reporting skills
- Prior regulatory submission experience
- Thorough understanding and experience with data quality and compliance checks
- Experience in software development life cycle (e.g., gathering user requirements, creating technical specifications, developing code, creating, and driving test plans).
- Familiar with R Programming language
- Statistical programming experience in a clinical development environment
- Experience working effectively in a globally dispersed team environment with cross-cultural partners
- Ability to lead and manage programmers in the successful and timely completion of all programming activities for a study or multiple studies from end to end
- Prior staff development leadership and project management experience
- Excellent oral and written communication skills
- Ability to effectively perform complex statistical programming and related tasks.
Benefits
Comp & perks- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Statistical ProgrammingSAS GraphSAS STATSAS MacroSQLR ProgrammingData Quality ChecksAdvanced SAS AnalysisSoftware Development Life CycleStatistical Analysis
Soft Skills
Excellent Communication SkillsCoaching and MentoringLeadershipProblem SolvingTeam Collaboration