Vijaya Maroju
Boxborough,USA
Summary
A highly accomplished Director of Statistical Programming with over 22 years of industry experience with industry experience in the analysis of clinical trial data (Phase I, II, III and IV) across multiple therapeutic areas (Oncology, Gene Therapy, Neurology, Pulmonary Diseases, and Respiratory Diseases). Proven track record of successfully leading and managing statistical programming teams, timely delivery of high-quality results in fast-paced and dynamic environments. Strong analytical skills, proficient in SAS, and adept at collaborating with cross-functional teams. Expertise in industry data standards, including CDISC, SDTM, and ADaM. In-depth understanding of regulatory requirements, and Good Clinical Practice (GCP), ICH guidelines and, 21 CFR Part 11 requirements. Proven ability to manage CRO relationships and oversee programmed deliverables. A proven track record of overseeing vendors. Extensive experience supporting and leading NDA/BLA and MAA submissions. Ability to work within cross-functional global teams and possess effective communication skills, interpersonal skills, and organizational abilities. Strategic-thinking individual experienced in turning low-performing organizations into top revenue producers. Offering engaging and pleasant personality with expertise improving customer relationships.
Overview
28
28
years of professional experience
Work History
Director/Head of Statistical Programming, Biometrics
Bluerock Therapeutics
09.2022 - 10.2024
- Contributed to selection and management of CROs for statistical programming activities for Phase study to Assess Safety and Tolerability of Human Embryonic Stem Cell-Derived Midbrain Dopamine Neuron Cell Therapy (MSK-DA01) For Advanced Parkinson's Disease
- In collaboration with Biometrics and IT departments, established GxP-compliant statistical computing environment and AWS cloud platform for data sharing, file transfer, and data storage between Bluerock therapeutics and contract resource organizations
- Involved in implementation of Elluminate Data Central to integrate clinical trial data from all sources into one platform
- Served as biometrics representative for Veeva's QualityDocs implementation.
- Developed and implemented strategies for optimizing statistical programming processes, leading to increased efficiency and productivity
- Collaborated with statisticians, study coordinators, and other key stakeholders to ensure accurate interpretation of data and meet project timelines
- Involved in Elluminate implementation for integrated data review
- Lead development of departmental processes and initiatives focused on operational excellence, resource optimization, standardization, automation, and CDISC standards implementation
- Provided oversight of budgets, resources, and timelines for contract research organizations (CROs) for multiple studies
- Developed SOPs, WIs for statistical programming
- Established programming team by recruiting and mentoring statistical programmers
- Managed end-to-end statistical programming projects outsourced to contract resource organizations
- Performed hands-on execution of all statistical programming activities (SDTM, ADaM, TFL development) as needed
- Represented statistical programming in cross-functional teams and contributed to process improvement initiatives
- Supervised work of internal and contract programmers, providing guidance, coaching, and career development
- Conducted data reviews for ongoing studies in collaboration with cross-functional teams
- Involved in design and development of Case Report Forms and edit checks.
Associate Director, Global Biometrics and Data Management
Pfizer
12.2013 - 07.2022
- Managed programming deliverables at study-level (i.e., clinical study report outputs, BR and EU outputs, DMC, QSRs, interim analyses), asset level (i.e., investigator brochure), and submission (i.e., study datasets in FDA standard format, ISS, ISE, RMP, label reports, etc.) for oncology studies.
- Developed timelines, resources, and project management for clinical study data analysis and reporting in collaboration with drug development project teams and department management
- Ensured excellence in delivering data sets, tables, listings, and figures analysis ready to advance research, development, and commercialization of Pfizer product portfolio
- Coordinated submission activities and provided functional input into regulatory documents and interactions
- Coordinated with cross-functional teams, statisticians, clinicians, and others to clarify points of ambiguity to ensure clear, concise, complete specifications for programmed deliverables
- Hired and mentored statistical programming staff as required.
- Involved in developing CRFs and database designs, including in-depth critical reviews of global standards.
- Contributed to SPA summer internship planning and mentored new hires and interns
- Led teams of up to 8 personnel, supervising daily performance as well as training and improvement plans.
Senior Consultant -Statistical Programming
Millennium Pharmaceuticals (Takeda)
03.2013 - 11.2013
- Programming support for studies regarding multiple myeloma, metastasizing castration-resistant prostate cancer, and Hodgkin's lymphoma (HL).
- Developed SDTM/ADaM datasets and tables/listings/figures for regulatory submissions, RMPs, IBs, interim analyses, and ad-hoc requests
- Developed statistical analysis outputs to support final reports, abstracts, posters, and manuscripts
- Worked closely with biostatisticians, clinicians, and other team members to deliver the statistical outputs
- Validated SDTM/ADaM data sets and TLFs for outsourced studies
Clinical Programming Lead
Wyeth Research (Pfizer)
09.2008 - 12.2012
- Provided programming support for studies in Phase II (Subjects with Advanced Lung Cancer and Advanced Breast Cancer) and Phase III (Women with Breast Cancer)
- Created and validated analysis datasets, tables, listings, and figures for various purposes, including CSR, SRT, DRV, publications, and interim assessments. Developed datasets according to CDISC SDTM and ADaM standards. TLFs were generated based on Statistical Analysis Plan, Clinical Data Presentation Plan, and statistical programming SOPs.
- Worked closely with biostatisticians and other members of team to ensure that deliverables met requirements
Senior SAS Programmer
Sepracor (Sunovion)
09.2005 - 09.2008
- Performed programming for Phase II study of Sep-225289 to treat depression, Phase II study of Arformoterol Tartrate Inhalation Solution and Racemic Formoterol in pulmonary patients with mild or moderate chronic obstructive pulmonary disease (COPD), and a Phase IV study of Lunesta to treat insomnia.
- Provided programming expertise for various purposes, such as CSR's, DSMB's, interim analyses, submission (ISS, ISE, datasets) and manuscripts.
- Developed SAS programs for internal studies based on the statistical analysis plan, datasets and TLF specifications, CDISC (SDTM,ADaM ) standards, and conventions.
- Validated the ADaM, SDTM datasets and tables developed by CRO for outsourced studies.
Statistical Programming Lead
Antigenics
05.2004 - 06.2005
- Served as lead for all programming deliverables for phase II stage liposomal cancer treatment, Aroplatin
- Oncophage, a phase III study for personalized vaccine development for Lymphoma and Metastatic Melanoma, AG-702, a phase I study for the treatment of Genital Herpes, AG-858, a phase II study for the treatment of chronic Myelogenous Leukemia
- Generated tables, listings, and figures for final study report, ISS, ISE, annual reports, publications, and ad hoc analysis
- Worked closely with data management, biostatisticians, and study investigators to meet specific data analysis and reporting requirements
- Extracted data from Oracle Clinical and generated CDISC compliant analysis datasets for FDA submission
- Performed quality control of standard and custom data listings, summary tables, and figures, as well as derived data sets and accompanying specifications
- Reviewed statistical analysis plans and assisting in the design of statistical data displays
- Lead development and documentation of analysis datasets specification
- Performed QC and documentation of tables and all datasets including algorithms for derived variables, description and purpose of datasets, common variables etc.
Senior SAS Programmer
Epix Pharma
09.2003 - 03.2004
- Provided programming support for phase-III, multi-center study to determine safety and efficacy of MS-325 enhanced MRA in patients with peripheral vascular disease
- Based on SOPs and statistical analysis plan, SAS programs were developed using SAS/Base, and SAS/Macro to generate tables, listings, and figures for final study report, publications, and ad hoc analysis
- All deliverables were validated and documented thoroughly for future reference
Programmer
Compuware Corporation
11.1998 - 03.2002
- Programmed TLFs for clinical study reports, ad hoc analysis, annual reports, and ad hoc reports
- Developed code in SAS to produce safety and efficacy reports, listings, tables, and graphs according to specifications of study protocol and statistical analysis plan
- QC of analysis datasets and TLFs
- Collaborated closely with Statistician, DM, and clinician to meet specific data analysis and reporting requirements
Software Developer
Progressive Tool & Industries
02.1997 - 09.1998
- Developed an application to maintain shipping information, Supplier, customer details, transportation, vehicle details, and employee work hours
- Developed detailed summary reports to retrieve data from shipping system based on various parameters
- Created reports to analyze employee attendance data, which is used to process payroll, employee benefits and employee reviews
- Developed screens to track labor charges spent by each department and project
- Involved in application development for employee training information
- Screens were developed to enter and update training schedule, course details, departmental training requirements, employee skill assessments and student/instructor details
- Developed reports to retrieve employee training details, budget spent on each training program based on various parameters
Education
Master of Business Administration -
University of Rhode Island
Kingston, RI01.2021
Master of Technology - Biotechnology
Jawaharlal Nehru Technological University
Hyderabad, India01.1995
Master of Science - Life Sciences
University of Hyderabad
Hyderabad, India01.1991
Bachelor of Science - Biology
Osmania University
Hyderabad, India01.1989
Skills
- Broad experience across multiple therapeutic areas and all phases of clinical trials
- Experience in regulatory submissions
- Expert at SAS programming
Personal Information
Visa Status: US Citizen
Timeline
Director/Head of Statistical Programming, Biometrics
Bluerock Therapeutics
09.2022 - 10.2024
Associate Director, Global Biometrics and Data Management
Pfizer
12.2013 - 07.2022
Senior Consultant -Statistical Programming
Millennium Pharmaceuticals (Takeda)
03.2013 - 11.2013
Clinical Programming Lead
Wyeth Research (Pfizer)
09.2008 - 12.2012
Senior SAS Programmer
Sepracor (Sunovion)
09.2005 - 09.2008
Statistical Programming Lead
Antigenics
05.2004 - 06.2005
Senior SAS Programmer
Epix Pharma
09.2003 - 03.2004
Programmer
Compuware Corporation
11.1998 - 03.2002
Software Developer
Progressive Tool & Industries
02.1997 - 09.1998
Master of Business Administration -
University of Rhode Island
Master of Technology - Biotechnology
Jawaharlal Nehru Technological University
Master of Science - Life Sciences
University of Hyderabad
Bachelor of Science - Biology
Osmania University
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