Manager, Statistical Programming

Cranbury, NJ /
Clinical Development – Biostatistics /
Full Time
/ Hybrid
Work at ROCKET PHARMA and help cure rare diseases!

Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues.  We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

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.

Responsibilities:

    • 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.

Requirements:

    • 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 
A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.

Full COVID-19 vaccination is required for employment at Rocket Pharmaceuticals.