Manager Statistical Programming
Category: Scientific & Clinical
Compensation Range: 140000.00 - 160000.00
Job ID: 287379
Date Posted: 03/13/2023
Manager, Statistical ProgrammingNJ, Hybrid role (2-3 days on office)
The Manager, Statistical Programming is a member of the Biostatistics team and plays a lead role in performing all SAS programming tasks required for clinical trial analysis and reporting. This individual works closely with Clinical Development, Biostatistics, and Data Management colleagues on various clinical projects, and may function as the lead statistical programmer on multiple projects.
- Manages assignments and programming on multiple projects.
- Participates in the development of and ensures compliance to Standard Operating Procedures (SOPs), policies, and guidelines.
- Remains informed of new developments in programming that are relevant to the industry and contributes to the innovation of new reporting systems.
- Establishes and implements programming standards and complies with regulatory requirements among project team members and across studies.
- Develops standard macros and/or tools in SAS for data analysis and reporting.
- Assists with statistical quality assurance review.
- Reviews deliverables before transfer to either internal or external clients.
- Ensures that SAS programs developed for specific protocols are effectively translatable to other protocols (reusable code).
- Performs the work of statistical programming services across sites to achieve quality, timely, and cost-effective study deliverables.
- Responsible for hands-on programming for ADaM datasets and TLF deliverables.
- MS degree in statistics or computing-related field or equivalent training required
- A minimum of 6 years of industry or CRO experience required.
- Experience leading SAS programming projects in the pharmaceutical industry, demonstrated by the ability to independently act as the point of contact for statistical programming over all phases of clinical trials.
- Proficient in industry standards, medical terminology, and clinical trial methodologies.
- Possesses project management skills within the Statistical Programming function.
- Regulatory (FDA and EMA) submission experience (including CDISC preparation) is highly preferred
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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