Binbin Zhang Email and Phone Number
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• 20+ years pharmaceutical statistical programming experience with 10+ years of programming management experience—with heavy recent emphasis on oncology and neurology products.• 10-year track record of success leading global submissions and supporting approvals of several blockbuster drugs, handling agency (FDA, EMA, MHRA, Health Canada, PMDA, etc.) inspections and responding to urgent requests from regulatory agencies.• Spearhead the comprehensive technical aspects of statistical programming across all Phase I-IV clinical trials, ISS, and ISE; strong hands-on technical experience with Macros, datasets, TLGs, BIMO and eSUB.• Experience leading 15+ initiatives to enhance efficiency, streamline processes, reduce cost, and foster innovation.• Expert knowledge of clinical trial development, ICH, regulatory guidelines, CDISC, industry standards and SOPs.• Strong leadership directing a statistical programming team with 20 programmers, across both US and UK sites, including extensive work in team-building, employee mentoring, engagement, and retention • Superior communication, interpersonal, executive skills, and cross-functional collaboration skills. • Extensive expertise in managing CROs, coordinating resource allocation, overseeing budgeting, implementing cost-saving measures, and conducting regular periodic financial reviews.• Collaborate with internal IT staff, ITQA, and IT vendors to create system infrastructure, manage multiple systems, drives and platform accesses—ensuring data integrity and system security.
Eisai Us
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Sr Director In Statistical Programming (Oncology Statistical Programming Head)Eisai Us Feb 2022 - PresentNutley, Nj, Us• Develop strategic and operational goals for Statistical Programming team for 5+ compounds.• Led over 10 global submission activities, serving as a technical expert in programming. Provide high-quality deliveries to agencies, which includes contribution to two accelerated approval submissions under the Breakthrough Therapy designation, as well as for the RTOR and ORBIS programs.• Vast experience with various agency inspections (FDA, EMA, MHRA, Health Canada, PMDA, etc).• Develop global macros and set up a macro library, including macro utility tools, programming standard, and data visualization tools. Create template programs for efficacy endpoints and TLFs. • Create Oncology guidelines/standards and provide programming expertise in SDTM+ and ADaM, data anonymization, narrative reports, biomarker analysis, BIMO and eSUB packages.• Coordinate business alignments with Merck, BMS, and Bliss Bio across three compounds. Support several drug License Agreements and regulatory transitions.• Lead standardization initiatives, including 15+ improvements to enhance efficiency, streamline process, write new SOP/SWPs, reduce cost, and foster innovation.
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Director, Statistical Programming (Deputy Oncology Statistical Programming Head In 2021)Eisai Us Nov 2019 - Jan 2022Nutley, Nj, UsIn addition to some of the responsiblity listed in Sr. Director• Collaborate with IT, ITQA, and IT vendor to design, establish and improve Eisai’s system infrastructure. Manage system access and version controls, ensuring data traceability and integrity, as well as maintaining system security. This encompasses supporting disaster recovery protocols, regular software updates, and system capacity monitoring, servers’ migration and decommission, etc.• Provide extensive programming expertise to CROs and participate in CRO qualification evaluation, vendor selection, bid review and budget negotiation.• Allocate resources among FTEs and contractors, ensuring optimal alignment and distribution. Oversee budgeting, implement cost-saving measures, conduct regular financial reviews, and apply resource reduction as needed. • Built and manage a highly motivated team of 20 statistical programming professionals. Establish and empower leaders in the team. Mentor colleagues within and outside of the Statistical Programming team.• Cultivate and maintain connections and relationships across multiple functions.
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Associate Director, Statistical ProgrammingEisai Us Jul 2014 - Nov 2019Nutley, Nj, UsLeadership in expertise and functional team building with highly motivated teams, systematic libraries and resources establishment, process enhancement with regulatory compliances, and standardization for cross compounds and global programming initiatives, active interactions with other functional teams. Contributions include leading comprehensive on time and good quality deliveries towards multiple global submissions. Organized multiple training across sites with insightful lesson and learns.
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Sr Manager, Statistical ProgrammingEisai Us Oct 2012 - Jul 2014Nutley, Nj, UsLed multiple EU and US submission activities.
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Senior Manager Statistical ProgrammingNovartis Jan 2012 - Sep 2012Basel, Baselstadt, Ch• Created global oncology efficacy dataset macros and lab dataset macros, set up macro library, and created new programming standards in standardization group.• As compound lead, led the submission with Pivotal study, ISS, and submission packages. Managed more than 10 phase I-IV studies under the compound. Supported blockbuster drug Everolimus submission.• Hands-on in-depth experience developing ADaM datasets and TLGs. • Managed resources in the US and India with a team of 9 programmers. Coordinated resource and workload across multiple locations: Paris, Basel, US, and India. Mentored many junior colleagues. • Oversaw and supervised multiple CROs• Led cross-functional collaboration with clinical, data management, drug regulatory, publishing, marketing and other line functions. -
Senior Statistical AnalystNovartis Mar 2005 - Dec 2011Basel, Baselstadt, ChLed EPO submission in US; Played major role in RAD submission in Europe in 2007. Oversaw and superwised multiple CROs, oversaw the work from India colleagues. Mentored for many oncology colleagues. Led more than 10 phase I-IV trials, safety updates and IB updates.
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StatisticianPpd Cro Sep 2004 - Mar 2005• Supported clinical development plans, complex study designs and feasibility assessments.• Wrote SAP and Shell for multiple pharmaceutical and biotech company clients.• Performed senior output review for delivery packages. • Developed QC programs to check the analysis and reports. • Ensured accurate, statistical valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents.• Worked on Phase 1 to Phase 4 studies in multiple therapy areas, such as CNS (Migraine, epilepsy, bipolar, etc.), infection disease, and woman health and pain relief.• Managed project timelines and budgets. Performed project management for multiple clients.• Communicated closely with clients to provide timely service.
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Statitical AnalystEli Lilly And Company 2003 - 2005Indianapolis, Indiana, UsWorked on Phase IV Neuroscience studies and publications.
Binbin Zhang Skills
Binbin Zhang Education Details
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University Of North Carolina At Chapel HillBiostatistics -
Peking UniversityStatistics
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Eisai The Building Transformative Leadership Program
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Mit Sloan School Of ManagementArtificial Intelligence In Health Care Certificate
Frequently Asked Questions about Binbin Zhang
What company does Binbin Zhang work for?
Binbin Zhang works for Eisai Us
What is Binbin Zhang's role at the current company?
Binbin Zhang's current role is Sr Director Statistical Programminger | Expertise in ICH guidelines, CDISC, global submissions, Phase I-IV clincial trials, Macro, ISS, ISE, BIMO, eSUB, Team leadership, CRO, budget planning, IT infrastructure support..
What is Binbin Zhang's email address?
Binbin Zhang's email address is ch****@****ail.com
What schools did Binbin Zhang attend?
Binbin Zhang attended University Of North Carolina At Chapel Hill, Peking University, Eisai The Building Transformative Leadership Program, Mit Sloan School Of Management.
What skills is Binbin Zhang known for?
Binbin Zhang has skills like Clinical Trials, Biostatistics, Oncology, Sas, Cdisc, Clinical Data Management, Neuroscience, Cro, Project Management, Clinical Development, S+s, Biotechnology.
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