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Grant received a PhD in Statistics from the University of Minnesota in 1998 and a Bachelor of Science degree in Chemical Engineering, with additional majors in Statistics and Mathematics, in 1993. In recent years, Grant has worked mainly in the central nervous system (CNS) therapeutic area on projects including indications of Alzheimer’s Disease (AD), Parkinson's Disease (PD), Post-Traumatic Stress Disorder (PTSD), Lewy Body Dementia, Schizophrenia, and pain associated with Diabetic Peripheral Neuropathy (DPN) and fibromyalgia (FM),Grant joined SDC (Statistics & Data Corporation) as a Director, Biostatistics in February 2020. SDC has provided strategic scientific consulting and clinical data services (biostatistics, data management/EDC, and IRT/IWRS) to pharmaceutical, biologic, and medical device/diagnostic companies since 2005.His most recent prior position (from September 2018 to November 2019) was Director, Biostatistics at Aptinyx Inc., a clinical-stage biopharmaceutical company that specializes in discovering and developing transformative therapies for challenging disorders of the brain and nervous system. Grant was accountable for the statistical soundness of all statistical outputs and deliverables, as well as developing and overseeing Biostatistics operations to ensure accurate information processing, data integrity, quality, and efficiency.From October 2017 to September 2018, Grant was a statistician at Pentara Corporation, a CRO which specializes in Alzheimer’s Disease (AD) clinical study design and efficacy analysis.In 2006, Grant joined Takeda as a Manager in Statistics, was responsible for several oncology projects, and led an Analytical Science team responsible for responding to regulatory requests for ACTOS (pioglitazone). Following a merger with TAP Pharmaceuticals, Grant transitioned from management into a full-time technical role. Subsequently, Grant participated in co-development of alliance partnership projects with Affymax for treatment of anemia due to chronic renal failure and with Zinfandel Pharmaceuticals for delaying Mild Cognitive Impairment (MCI) due to Alzheimer’s Disease.Before joining Takeda, Grant worked at Quintiles, serving as Randomization Team Lead, Manager, and then Associate Director. Grant also served as the Lead Statistician on a series of global asthma studies, culminating in a US FDA NDA submission. Grant’s earliest experience, at Hoechst Marion Roussel, was serving as a statistician on an anemia FDA BLA submission program with 4 Phase II/III studies.
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Director, BiostatisticsSdc (Statistics & Data Corporation) Feb 2020 - May 2022Tempe, Arizona, UsLead Biostatistics team in Phase I-IV and medical device clinical trials.• Manage statistical and statistical programming activities involved in the design, analysis and interpretation of clinical trials data conducted by SDC.• Supervise and direct staff, both permanent and temporary, to include assignment of work, allocation of statistical resources and management of timelines to ensure contractual obligations and objectives are met.• Serve as a consultant with internal and external cross-functional areas regarding statistical operations.• Function in the role as Senior Biostatistician on clinical trial(s) as required.• Functions as a senior reviewing statistician, responsible for the timeliness and quality of departmental deliverables.• Assess operational needs and requirements; ensure efficient allocation of resources and adequate staffing to meet goals and objectives of the department.• Contribute to the development of standard operating procedures for clinical trials; ensure that statisticians and statistical programmers appropriately interpret and follow procedures.• Prepare reports that summarize the analysis of data, interpret findings and provide conclusions and recommendations.• Represent statistical operations department at regulatory meetings, sponsor meetings, and any other multifunctional meetings.• Adheres to all aspects of the SDC's quality system.• Complies with SDC's data integrity & business ethics requirements. -
Director, BiostatisticsAptinyx Inc. Sep 2018 - Nov 2019Evanston, Il, UsKey Roles & Responsibilities:● Develops and oversees Biostatistics operations to ensure accurate and efficient information processing and data integrity and quality.● Manages complex projects and is accountable for the statistical soundness of all statistical input and deliverables for assigned projects.● Supports interactions with regulatory authorities and key opinion leaders.● Collaborates with clinical teams on available clinical trial designs and statistical methodologies and their application in drug development, ensuring that the department stays at the forefrontof statistical methodologies in CNS drug development.● Participates in establishing strategy and direction within clinical research to ensure that appropriate data management techniques and principles are applied.● Designs, develops, modifies and evaluates a technical infrastructure to expedite conduct and evaluation of clinical trials and basic research.● Facilitates and oversees creation of standards with respect to key variables, definitions, statistical methods, data structures and presentation of data.● Stays at the cutting edge of methodology development in statistics, regulatory guidelines, and industry trends in drug development, and signals relevant developments in a timely manner for the company.● As needed, participates in reviewing in-licensing opportunities and due diligence activities, reviews data and advises company. -
StatisticianPentara Corporation Oct 2017 - Sep 2018Key Roles & Responsibilities:• Researched choice of optimal primary efficacy endpoints for Alzheimer’s disease and Parkinson’s disease trials.• Provided sample-size/power calculations for proof-of-concept (POC), bioequivalence, and drug-drug interaction (DDI) studies using R packages/functions and PASS software.• Reviewed protocols, SAPs, TFLs, CSRs, and draft manuscripts.• Contributed to writing and revision of protocols, SAPs, statistical reports, CSRs, and draft manuscripts.• Increased familiarity and proficiency with SAS and R programming.• Researched and contributed to analyses using global test statistics, principal component analysis, multiple imputation (using the R package “Amelia”), propensity score analysis, and model selection (using SAS PROC GLMSELECT).
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Principal StatisiticianTakeda Nov 2006 - Oct 2017Tokyo, JpProject StatisticianManager, StatisticsKey Roles & Responsibilities:• Serving as Lead Statistician for a co-development project (currently in Phase 3) on the continuum from cognitively normal to MCI related to Alzheimer’s Disease with alliance partner Zinfandel Pharmaceuticals.• Provide strategic statistical input and contribute to Clinical Development Plans (CDPs), protocols, study reports, regulatory communications and responses, and other project documents.• Interact with and perform external vendor management of CROs and Interactive Voice Response (IVR) vendors, including vendor selection and review of proposals, budgets, specifications, and deliverables (e.g., eCRFs, Data Validation Plans, SAPs, datasets, and TLFs).• Served as Takeda Lead Statistician for peginesatide (Omontys) co-development project with alliance partner Affymax for an NDA which was submitted to the FDA in May 2011.• Performed functional line management of a group of statistical staff, including technical review/assistance on project issues, timelines, etc.• Led an Analytical Science team responsible for responding to regulatory requests for ACTOS (pioglitazone). -
Associate Director, StatisticsQuintilesims Jan 1999 - Oct 2006Durham, North Carolina, UsManager, StatisticsStatistical ScientistSenior BiostatisticianKey Roles & Responsibilities:• Performed functional line management of a group of statistical staff, including technical review/assistance on project issues, timelines, etc.• Assisted Director in charge of hiring with recruiting of new statisticians and statistical interns.• Reviewed/prepared study protocols and discussed strategies with clients regarding study design and complex analysis issues, FDA issues, and general drug development.• Served as an expert reviewer for Biostatistics; reviewed protocols, analysis plans, TLF shells and TLFs, study reports, integrated summaries, and other NDA report sections.• Monitored budget, scope of work, and project risks for ongoing projects; participated in project review and operations meetings.• Participated in proposal development, budget preparation, and sales meetings.• Served as Lead Statistician on a 15-study asthma FDA NDA submission program and 120-Day Safety Update.• Coordinated teams of statisticians, statistical programmers programmers, and QC reviewers to meet project and client objectives, including preparation of submission-ready STDM and ADaM datasets and Data Definition Tables (DDTs).• Served on Randomization Team, ending service as Randomization Team Lead.• Served as a statistician on an anemia FDA BLA submission program with 4 Phase II/III studies. -
Associate Statistical ScientistHoechst Marion Roussel Inc. Sep 1998 - Dec 1998• Served as a statistician on an anemia FDA BLA submission program with 4 Phase II/III studies.
Grant Runyan Skills
Grant Runyan Education Details
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University Of MinnesotaStatistics -
Iowa State UniversityTriple-Major: Degree In Chemical Engineering With Additional Majors In Statistics And Mathematics
Frequently Asked Questions about Grant Runyan
What is Grant Runyan's role at the current company?
Grant Runyan's current role is Director, Biostatistics.
What is Grant Runyan's email address?
Grant Runyan's email address is gr****@****cal.com
What schools did Grant Runyan attend?
Grant Runyan attended University Of Minnesota, Iowa State University.
What skills is Grant Runyan known for?
Grant Runyan has skills like Biostatistics, Statistics, Clinical Trials, Clinical Development, Pharmaceutical Industry, Cro Management, Drug Development, Regulatory Submissions, Alzheimer's Disease, Clinical Research, Statistical Analysis Plans, Cro.
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