Associate Vice President, Biostatistics and Data Management
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 ideal candidate will have diverse Biostatistics and Data Management (DM) senior leadership experiences, will be hands on and driven to direct and contribute broadly to Biostats and DM functional initiatives and actively participate in the development, implementation and oversight of clinical programs. This position is also responsible for the management and ongoing development of Rocket’s Biostats/programming and DM teams and their overall performance.
Responsibilities:
- Establishes and meets project management requirements by incorporating cross functional processes between biostatistics and data management, and ensuring integration with clinical operations, clinical development, regulatory, pharmacovigilance and additional functional areas as required.
- Leads the team in the development and implementation of statistical and data management standard working practices along with preparations and requirements for regulatory inspections and/or submissions.
- Directs the planning, coordination, gathering, implementation and process improvement necessary to meet any cross-functional statistical planning and data quality requirements for clinical trial conduct and analysis.
- Participates in strategic planning for protocol and new program initiatives with emphasis on statistical underpinning of study size and duration.
- Ensures that Biostats/DM capabilities enable the translation of corporate and clinical team objectives into operational actions and maximize available technical platforms to assist in completing project objectives.
- Responsible for vendor management and performance, and key internal and vendor deliverables.
- Organizes and maintains operational continuity across multiple studies and programs
- Contributes to establishment of global data standards and authorship of standard operating procedures
- Participates in the budget process and ongoing fiscal oversight.
- Assists in creating data visualizations, as required, for presentations
Requirements:
- Masters or doctorate in statistics or related scientific, healthcare, medical and/or bioinformatics/computer science discipline. Requisite biopharma industry experience indicated above.
- 15+ years of proven career development, growth, advanced skills, and accomplishments
- Must have relevant project initiative leadership in clinical-stage biostatistics and/or data management in the pharmaceutical/biotechnology industry.
- Past experiences with inspection readiness, regulatory submission and effective CRO oversight
- Excellent organizational skills, highly collaborative & supportive, attention to detail, communication, time management, and flexible attitude with respect to work assignments
- Embraces new learning and demonstrates strong ability to communicate and interact in a team environment.
- Expertise in industry and regulatory standards (FDA and/or EMEA Regulations, ICH Guidelines, and GCP)
- Proficient in multiple EDC platforms, related processes, and data visualization/graph tools, i.e.: Power BI, Tableau, SAS VA, GraphPad, etc.
- Extensive knowledge of SAS, SQL, database design and database concepts
- Strong knowledge of CDISC standards (CDASH/SDTM)
- Experience in the design/analysis of early- and registration-stage programs and with both internal and external control datasets
- Progressive minded, very organized and creative problem solver
- Deep knowledge of related regulations, GCP and Good Clinical Data Management Practices
- Strong knowledge of medical terminology including capable background in clinical laboratory assessments and terminology
- Understanding of coding (MedDRA, WHO drug dictionaries)
- Comfortable in a fast-paced small company environment with ability to manage a variety of projects simultaneously and handle rapidly changing information.
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.
