The Senior Director, Biostatistics leads a Therapeutic Area comprising of two or three gene therapy clinical programs in rare diseases. The person in this position will be an important member of the Global Program Teams and cross-functional study teams and will be responsible for all statistical activities of the clinical programs, including statistical input to development strategy, clinical trial designs, statistical components of protocols, statistical analysis plans, planned and exploratory analyses, interpretation and communication of analysis results, and worldwide regulatory submissions.

• Responsible for all statistical aspects of clinical development programs of the assigned Therapeutic Area, including development strategies from first-in-human trial to life cycle management, clinical studies, and regulatory submissions (e.g., BLA and MAA)
• Leads collaboration with internal and external (e.g., CRO) team members to coordinate the planning and execution of statistical deliverables
• Leads/conducts statistical modeling to enable innovative and optimal statistical designs and to address identified or potential statistical issues arising in programs or studies
• Contributes to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles
• Authors or oversees statistical analysis plans for clinical trials and integrated summaries of safety/effectiveness (ISS/ISE), and oversees the development of shells for tables, figures and listings
• Reviews case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses
• Designs and specifies randomization schedules; reviews and approves test randomization lists
• Provides statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents
• Provides guidance to statistical programmers on ADaM and tables/figures/listings
• Ensures QC/QA of statistical deliverables including validation of key analysis results
• Performs ad hoc and exploratory statistical analyses as needed
• Provides statistical input to natural history studies based on program goals such as understanding of the endpoints and potential need of external control analyses
• Contributes to clinical study reports, DSUR and CTD sections 2.7.3 and 2.7.4, including authoring of statistical methods and interpretation of analysis results
• Addresses statistical questions/comments from FDA and other regulatory agencies, and reviews and addresses comments by IRB/ECs
• Supports and ensures the data accuracy of publications including manuscripts and presentations
• Contributes or leads standardization and process improvement efforts for Biostatistics and contributes to cross-functional process improvement efforts
• Represents Rocket regarding statistical issues in meetings with regulatory agencies and other external parties
• Oversees statistical vendors in collaboration with Statistical Programming with respect to key performance indicators, metrics, and key deliverables and timelines
• Contributes to project budget/resource planning, re-forecasting, and milestones, in collaboration with other functions
• Serves as a mentor to junior team members as applicable

• Ph.D. or Master degree in Statistics or a related field
• At least 10 years (15 years for Master) of experience in the pharmaceutical/biotech industry
• Demonstrated ability and experience in the design, analysis and reporting of clinical trials
• Experience in leading statistical activities for NDAs, MAAs or other regulatory submissions
• In-depth knowledge of statistical methods for clinical trials, including both frequentist and Bayesian approaches
• Experience with rare diseases or gene therapies are desirable but not required
• Knowledge of FDA, EMA and ICH regulations and guidelines
• Proficient in statistical programming (SAS and R)
• Proven ability to use statistical simulations to account for uncertainty and in scenario planning for study design and key analyses
• Experience with trial design software (e.g., EAST or nQuery)
• Strong organization skills and ability to concurrently work on multiple programs/studies
• Familiarity with CDISC standards, including SDTM and ADaM
• Adept at overseeing statistical services provided by CRO’s and/or contractors
• Ability to work independently and act with initiative to address issues and solve problems
• Ability to effectively communicate statistical concepts in a clear and concise manner both written and verbally
• 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.