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Form of workWork 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.
As the Director, Statistical Programming, the person in this position will provide Statistical Programming expertise and leadership for the function, and will be responsible for developing and maintaining Statistical Programming processes, standards and systems, planning and managing Statistical Programming resources to meet business needs across all clinical programs, and playing a key role in oversight of statistical vendors. The incumbent will also take on the role of Statistical Programming Lead for clinical programs as needed.
- Responsible for all aspects of Statistical Programming function, including processes, project timelines, quality, and talent.
- Develops and implements processes (e.g., SOPs and WIs) and standards consistent with regulatory requirements and best industry practice for Statistical Programming function with mainly outsourcing and some in-house activities; contributes to development of cross-functional processes and standards
- Leads cross-program productivity and compliance initiatives in Statistical Programming
- Effectively engages cross-functionally to advance projects and initiatives
- Provides strategic and technical expertise in Statistical Programming for clinical development programs and regulatory submissions
- Forecasts and manages Statistical Programming resources to meet current and future business needs; establishes and maintains vendor partnerships
- Ensures proper role and contribution by Statistical Programming in various stages of clinical studies, including review of case report forms, review of statistical analysis plans, development of shells for tables, figures and listings, programming support of data cleaning, ad hoc and exploratory analyses, interim and final analyses, publications, etc.
- Leads Statistical Programming efforts for BLA, MAA and other regulatory submissions, including SDTM and ADaM datasets and associated define files, tables/figures/listings for integrated summaries (ISS and ISE), etc.
- Leads Statistical Programming efforts to support innovative statistical approaches and meta-analyses
- Represents Rocket as Subject Matter Expert on clinical data submission in meetings with FDA and other regulatory agencies; and provides leadership in addressing clinical data submission questions/comments from FDA and other regulatory agencies
- Responsible for recruiting, coaching, mentoring, and performance management of direct reports
- Master’s degree in statistics, computer science or a related field
- At least 12 years of Statistical Programming experience in the pharmaceutical/biotech industry
- At least 2 years of experience in leading/managing a Statistical Programming team
- Extensive experience in project management of Statistical Programming activities
- Proven ability to manage CRO relationships and oversee programmed deliverables
- Extensive experience in leading Statistical Programming function for both early and late phase clinical trials, and regulatory submissions (NDA/BLA, MAA)
- Excellent skills in SAS programming and statistical reporting
- Knowledge of R and R Shiny desirable
- In-depth knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements
- Familiarity with FDA and ICH regulations and guidelines
- Excellent problem-solving skills
- Excellent written and verbal communication skills and organizational and documentation skills
- Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, etc.
- Ability to prioritize and multi-task effectively
- Ability to collaborate, communicate and interact effectively in a fast-paced team environment
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.
