Associate Director Data Analyst

TONY T. SALEHI

302-***-**** **********@*****.***

Professional Summary

Accomplished Associate Director with 14 years of Oncology experience in statistical programming, management of statistical programmers, and CDISC data standards in delivering high-quality regulatory submissions. Background includes early work as a Data Analyst in AIDS research at Stanford University and extensive consulting as a SAS programmer across pharmaceutical and biotech companies. Recognized for implementing innovative, time-saving approaches to statistical analyses that support drug development and regulatory compliance. Key achievements include successful EMA and FDA submissions for Vidaza (MDS), Trobalt (Epilepsy), and critical interim analyses for Durvalumab (HNSCC, HCC). Adept at cross-functional collaboration, client engagement, and guiding teams through complex deliverables, with professional development strengthened by AstraZeneca's Influencing Masterclass.

Therapeutic Experience

Cardiovascular: Hypertension, MI, Stroke, Type II Diabetes

Oncology: Solid Tumors, Non-Hodgkin's Lymphoma, AML, MDS, ITP, NSCLC, HCC, RCC

Respiratory: Asthma, COPD, Cystic Fibrosis

Medical Device: Echocardiogram

Neurology: Epilepsy, Bipolar Disorder

CNS: Sleep Disorders/ Insomnia

Immunology: HIV/AIDS

Work History

Associate Director, Data Standards and Solutions 11/2023 to Current

Exelixis

Spearheaded the development and maintenance of Exelixis's Clinical Data Standards library in partnership with the Global Librarian, ensuring compliance with CDISC standards and consistency across oncology studies.

Provided subject matter expertise in clinical study teams, shaping CRF design, edit checks, data transfer specifications, and eCRF implementation guides, resulting in streamlined data collection and improved study efficiency.

Led cross-functional collaborations with clinical, statistics, programming, data management, and imaging stakeholders to create standardized eCRFs and metadata mappings from CRF/non-CRF to SDTM, supporting multiple oncology indications.

Directed cross-functional teams of data engineers, IT specialists, and 9 clinical programmers to migrate and validate CRO SAS programs, macros, and outputs across 9 clinical trials, ensuring 100% operational integrity on the Exelixis LINUX platform.

Spearheaded the development of standardized Data Transfer Plans by coordinating with 3rd-party vendors, optimizing onboarding processes through Digest, and streamlining data flow into Exelixis LINUX directories, reducing onboarding cycle time by 20%.

Partnered with Data Management, Clinical Science, and Patient Safety groups to establish clinical reporting and data onboarding standards, enhancing consistency and accelerating delivery of study metrics, SAE reconciliation, coding reports, and patient profiles.

Associate Director, Standards Governance (Immuno-Onc/Onc) 10/2020 to 11/2023

Astrazeneca Pharmaceuticals

Directed governance of oncology data standards by developing and implementing SOPs, CDISC/CDASH-compliant raw data specifications, and TLF templates, ensuring consistency and quality across clinical studies.

Partnered with TASALs, programmers, and data managers to resolve complex CSP, SDTM, and ADaM mapping queries, providing strategic oversight that enhanced compliance and streamlined end-to-end data processes.

Led cross-functional initiatives to optimize CRF design, iRECIST data collection/mapping, and automation tools, driving standardization efforts that improved efficiency and supported high-impact oncology programs.

Therapeutic Area Standards Automation Leader(TA-SAL) 05/2019 to 09/2020

Astrazeneca Pharmaceuticals

Directed the consistent application of corporate and therapeutic area (TA) end-to-end standards by reviewing clinical study protocols (CSPs), leading TASDT meetings, and optimizing corporate standards to ensure compliance and operational efficiency.

Spearheaded the design, validation, and enforcement of standard programming tools and automation—including SDTM mapping, ADaM macros, and CRToolKit—while developing standardized RECIST SDTM SAS programs integrating investigator and BICR data under RECIST1.1 and mRECIST guidelines.

Led cross-functional teams in the redesign and implementation of corporate eCRFs, while mentoring and training TA-SALs across the IO/O portfolio, establishing role guidelines, and driving the advancement of corporate/TA tools and automation.

Principal Programming Specialist 05/2018 to 05/2019

Astrazeneca Pharmaceuticals

Served as technical lead and subject matter expert for immuno-oncology Hepatocellular Carcinoma studies, designing and validating SDTM and ADaM efficacy datasets in compliance with RECIST 1.1 and mRECIST guidelines to support regulatory submissions and data integrity.

Developed and implemented advanced oncology programming tools, including CTC AE toxicity utilities, improving efficiency and accuracy of safety reporting across multiple clinical trials.

Mentored and trained junior programmers while fostering cross-functional collaboration with Strategic Partners, Biostatistics, and Data Solutions teams to drive consistency, optimize standard adoption, and ensure timely delivery of IDMC, IA, and IEMT outputs.

Global Project Programmer 03/2016 to 05/2018

Astrazeneca Pharmaceuticals

Directed end-to-end project-level programming strategy by defining deliverable scope, overseeing outsourcing activities, and aligning timelines with submission and reporting requirements, ensuring compliance with global regulatory standards.

Managed cross-functional programming deliverables—including IDMC, BDR, interim analyses, IEMT, and payer requests—by coordinating resources, monitoring risks, and driving timely, high-quality outputs across diabetes and oncology projects.

Supervised a team of 12 programmers (full-time and contract), assigning workload based on priorities, establishing milestones, and ensuring consistent adherence to AstraZeneca programming standards, data models (SDTM, ADaM), and reporting specifications.

Principal Statistical Programmer 03/2015 to 02/2016

PAREXEL International

Led the development of analysis-ready datasets and data displays (SDTM to ADaM) to support clinical projects, ensuring regulatory compliance and alignment with GSK data standards.

Partnered with cross-functional teams and outsourced operations to review, prioritize, and deliver statistical programming activities, achieving project milestones within established timelines.

Oversaw the creation and review of ADaM specifications, driving consistency across projects and ensuring high-quality programming outputs for study-level and in-licensed compound data.

Manager, Statistical Programming 03/2010 to 02/2015

GlaxoSmithKline

Directed cross-functional statistical programming efforts for clinical studies by creating analysis-ready datasets, generating regulatory-compliant data displays, and ensuring high-quality reporting deliverables across internal and outsourced teams.

Oversaw workload allocation between GSK and functional service providers (FSPs), negotiated contracts, and acted as the primary liaison to optimize resource utilization, streamline timelines, and maintain compliance with SOPs and regulatory standards.

Provided technical leadership and training in programming and reporting, reviewed statistical analysis plans (SAP/RAP), and coordinated study archiving processes to strengthen data integrity and support successful submissions.

Technical Programming Manager 01/2009 to 01/2010

Ockham Development Group

Directed and monitored programming workflows, ensuring project timelines and quality standards were consistently achieved across complex clinical studies.

Supervised and aligned programmer assignments with individual skill sets, optimizing task allocation to improve efficiency and accuracy of deliverables.

Collaborated as a key project team member on ITP and MDS studies, fostering clear communication and cross-functional alignment to support successful study outcomes.

Manager, Statistical Programming 01/2006 to 01/2009

Pharmion/Celgene Corporation

Directed and oversaw CRO statistical programming deliverables—including analysis datasets, QC plans, and TLG outputs—ensuring compliance with regulatory standards (FDA, EMA) and alignment with submission timelines.

Supervised and mentored a team of 4–6 senior programmers and contingent staff, driving efficiency in database specifications, data transfers, and analysis file development while maintaining high-quality standards.

Provided programming leadership for critical regulatory documents such as Investigator's Brochure, Annual Safety Reports, PSURs, and sNDA/EMEA submissions, strengthening data integrity and supporting successful global drug safety initiatives.

Associate Director, Statistical Programming 01/2005 to 12/2005

Quintiles Transnational (IQVIA)

Directed strategic HR initiatives for the Statistical Programming department, overseeing recruitment, promotions, performance management, and professional development programs that strengthened team capabilities and retention.

Assessed and forecasted staffing needs based on project pipeline, resource utilization, and delivery timelines, ensuring optimal allocation of 7–10 statistical programmers across high-priority projects.

Supervised and mentored a diverse team of entry-level programmers to senior technical advisors, fostering problem-solving skills, career progression, and sustained engagement to drive departmental performance.

Manager, Statistical Programming 01/2002 to 09/2005

Quintiles Transnational (IQVIA)

Directed statistical programming activities for multiple complex clinical studies, ensuring timely delivery of high-quality datasets, tables, and listings in compliance with regulatory and organizational standards.

Led and mentored a team of 4–7 statistical programmers and contingent staff, fostering skill development, collaboration, and innovative problem-solving to enhance departmental performance.

Partnered with cross-functional project teams to develop and implement efficient programming solutions, optimizing resource allocation and meeting critical project timelines.

Senior Analyst 01/2001 to 12/2001

Quintiles Transnational (IQVIA)

Spearheaded cross-functional projects as project manager and technical liaison, ensuring seamless collaboration across departments and delivering client proposals, presentations, and budget reviews with 100% on-time completion.

Planned, coordinated, and executed advanced statistical programming tasks for complex clinical studies, streamlining workflows and improving data accuracy by 20%.

Designed and implemented integrated databases consolidating multi-trial clinical data for single drug projects, enhancing accessibility and supporting faster regulatory submissions.

Statistical Programming Consultant 06/1994 to 12/2000

Chastain Research Group

Designed, developed, and validated SAS/SQL programs to support clinical trial data analysis, ensuring compliance with CDISC standards (SDTM, ADaM) and FDA/EMA regulatory requirements.

Collaborated with biostatisticians and data management teams to generate statistical outputs, including tables, listings, and figures, reducing programming turnaround time by 20%.

Conducted quality control (QC) and peer review of statistical programs, identifying and resolving data inconsistencies to improve accuracy and reliability of final study deliverables.

Data Analyst 04/1992 to 05/1994

Stanford University Medical Center

Developed and executed SAS programming solutions to support data management and statistical analyses for Phase II Oncology clinical trials, ensuring accuracy and compliance with regulatory standards.

Conducted advanced statistical analyses for AIDS-related research projects, delivering actionable insights that supported publication of study findings and investigator decision-making.

Advised investigators on data collection methodologies, data integrity, and quality assurance practices, resulting in improved accuracy and reliability of research datasets.

Education

B.S.: Statistics

California Polytechnic State University San Luis Obispo, California

Tools/Skills

Microsoft Office

Data Visualization

CDASH/CDISC

Data Quality Control

SAS (BASE, GRAPH, STAT, MACRO)

Leadership

Adaptability

Communication

Problem-Solving

Team Collaboration

Publications

A Macro Specializing in Adverse Event Reporting, Salehi, T., Moore, D., 2003, PharmaSUG

Work Process from Data Management to Final Analysis Creation, Salehi, T., 2001, MWSUG

Summary Of Technical Tools Skills

Twenty-eight years of experience in clinical trials research including statistical programming and reporting and over fifteen years of management of programming staff.

Spent two years as a data analyst in AIDS research at the Stanford University Department of Medicine and six years as a SAS programming consultant with various pharmaceutical and biotech companies.

Successfully utilizes skills and experience in statistical programming, management and leadership in drug development, to find creative and time-saving approaches in delivering the necessary analyses to both internal and external clients.

Completed EMA and sNDA submissions for Vidaza in the treatment of MDS.

Completed Interim Analyses and IDMC deliverables for Durvalumab in the treatment of both HNSCC and HCC.

Completed the EMEA and FDA submissions for Trobalt in the treatment of Epilepsy.

Participated in Astrazeneca's Influencing Masterclass.

Tools Skills - Software

Microsoft Office

SAS/BASE

SAS/GRAPH

SAS/STAT

SAS/MACRO

TSCG Graphics

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