Manager of Statistical Programming needed for growing team in the Princeton, NJ area. Ideally this persion will be onsite part of the time, but can consider a remote arrangement w/occassional travel
- 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