Manager, Biostatistics

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, Biostatistics is a member of the biostatistics and programming team and plays a lead role in performing all statistics tasks required for clinical trial analysis and reporting. This individual works closely with clinical development, statistical programming, and data management colleagues on various clinical projects, and may function as lead statistician on multiple projects.

Responsibiltiies:

    • Manages or leads biostatistics assignments on multiple projects.
    • Remains informed of new developments in biostatistics and programming that are relevant to the industry.
    • Establishes and implements biostatistics and programming standards and complies with regulatory requirements among project team members and across studies.
    • Programming in SAS and/or R for data analysis and reporting.
    • Assists with statistical quality assurance review.
    • Reviews deliverables before transfer to either internal or external clients.
    • Performs statistical services to achieve timely, quality, and cost-effective deliverables including SAP, TLF shells and dataset spec development.
    • Participates in the development of and ensures compliance to Standard Operating Procedures (SOPs), policies, and guidelines related to statistics and programming.
    • Hands-on programming for TLF deliverables required statistical inference.

Requirements:

    • MS degree in statistics or equivalent training required, PhD preferred
    • A minimum of 6years of industry or CRO experience required
    • Experience leading statistical projects in the pharmaceutical industry, demonstrated by the ability to independently function as the point of contact for statistics over all phases of clinical trials
    • Proficient in industry standards, medical terminology, and clinical trial methodologies
    • Possesses project management skills within the biostatistics function
    • Regulatory (FDA and EMA) submission experience is not required but is considered valuable for an optimal candidate
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.