Data Management Project
Resume:
PROFESSIONAL PROFILE
Ms. Collins has over ** years experience in statistical analyses and clinical data programming. She has worked on five projects that have met FDA approval and are on market. She was instrumental in producing two pooled summary of efficacy (ISE) and six safety statistical analyses (ISS), of which four turned into submissions. She has experience in five projects seeking new drug applications
(NDA) and one biologics license applications (BLA). She is experienced in SAS® statistical programming, clinical trial analysis concepts, and CDISC and ADaM standards, including SDTM domain and ADaM dataset development. Also development of tables, listings, and graphs, as well as CDISC standards and Item 11 data conversions. She has experience in producing eCTD documentation and Define-XML 2.0. and 2.1 and Analysis Data Reviewer’s Guide (ADRG.pdf) for some of the aforementioned submissions. She has more than 4 years of experience working on Oncology studies focusing on phases II and III, including biomarker data. She has also performed validation for systems related to clinical analysis.
EXPERIENCE
COMPETENCIES
Statistical Programming TLF’s
Clinical Programming
CDISC / ADaM / SDTM Standards
Item 11 Data Conversions
eCTD Documentation
ZYMEWORKS BIOPHARMACEUTICALS, 2021 - 2023
SENIOR STATISTICAL PROGRAMMER
Zymeworks Biopharmaceuticals Seattle, WA Jan 2022 – May 2023
• Accountable for production of statistics deliverables, acting as a key collaborator and strategic partner with biostatistics in ensuring that drug-development plans are executed efficiently with timely and high- quality deliverables.
• Developed SAS® programs to analyze and report clinical trial data for CSRs, Integrated Summary of Safety (ISS), regulatory submissions
(e.g., DSURs, NDAs/BLAs, briefing documents), publications, biomarkers, and presentations.
• Developed and maintained SDTM and ADaM data set specifications for clinical studies. Programmed SDTM and ADaM data sets and TLFs for clinical studies.
SARAH COLLINS
****************@*****.***
https://www.linkedin.com/in/sarah-collins-
2330b218
Fairfield, CA 94534
Senior Statistical Programmer
SYNESIS ANALYTICS, 2023 - 2025
CONSULTING PROGRAMMER
• Produced statistics deliverables for clients including the development of SAS® programs for SDTM and ADaM datasets as well as the TLF’s.
• Produced ADaM Define.xml 2.1 documentation for studies.
• Reviewed and contributed to the development of statistical analysis plans, TLF specifications, study CRFs, and database design specifications.
• Oncology
(Breast, Biliary, Solid Tumor,
Hematologic, Unresectable or
Metastatic Melanoma, Myelodysplastic
Syndrome (MDS),
Acute Myeloid Leukemia (AML),
Diffuse Large B-cell Lymphoma
(DLBCL), Nephropathic Cystinosis
• Friedreich Ataxia (FA)
• Alport Syndrome (ARAS)
• Neurology / Alzheimer’s Disease
• Hyperkalemia
• Hernia Post Surgical Pain
• Lou Gehrig’s Disease (ALS)
• Chronic Kidney Disease (CKD) /
• Nephrology Cardiovascular / Renal Disease Disease (CVD)
• Chronic Pseudomonas Aeruginosa
Infections
• Glabellar Lines in Adult Subjects
INDICATIONS
SAS®
SAS Macro
SAS SQL
Microsoft Office
Define.xml 2.0 / 2.1
Pinnacle 21
University of Massachusetts, Boston, MA 1988-1992
Coursework in Liberal Arts,
Credit Hours 71
Northeastern University, Boston, MA 1992-1992
Coursework in Physics,
Credit Hours 8
Harvard Extension School, Cambridge, MA 1992-1996
Coursework in Computer Science and Liberal Arts,
Credit Hours 20
EXPERIENCE Continued
CLINICAL PROGRAMMING CONSULTANT
Zymeworks Biopharmaceuticals Seattle, WA Jul 2021 – Jan 2022
• Supported Data Management team in cleaning data, scrubbing data, edit checks, data reviews, SDTM validation and producing reports using traffic lighting.
• Experienced with CDISC, SDTM validation and also with scrubbing data, edit checks and data reviews.
• Worked with Excel traffic lighting and created custom macros to generate output based on the criteria entered in specs.
• Worked on phase II-III oncology studies.
SKILLS
CERTIFICATIONS
• SAS® Certified Base Programmer – 2015
• SAS® Certified Clinical Trials
Programmer - 2015
PHARMASTAT, LLC, 2015 - 2021
STATISTICAL PROGRAMMER
• Produced analysis programs, tables and data listings as well as validation programs and validation documentation.
• Produced documentation for analysis datasets for submission to regulatory agencies.
• Responsible for writing specifications for ADaM programming conventions.
• Responsible for performing complex analysis on clinical trial study data through generation of tables and listings used in FDA submission documents.
• Performed quality control of data and outputs to ensure conformance with CDISC ADaM standards and FDA submission guidelines.
• Created Define-XML 2.0/2.1 documentation and in producing Item 11 data conversions and documentation.
• Worked with raw data (flat file conversion into SAS) and creating reports in Excel.
• Production of SDTM datasets and was trained on Pharmastat’s processes for its implementation and documentation. HYGIA BIOSTAT, INC, 2013 - 2015
PROGRAMMING INTERN
• Wrote and tested SAS® programs for data manipulation, quality control, and reporting of clinical trial data.
• Executed validation testing of reusable SAS® systems for Item 11 regulatory submissions, using SDLC (system development life cycle) methodology.
• During this time, passed two certifications in programming from the SAS Institute.
MEMBERSHIPS AND
AFFILIATIONS
• Attendee, PharmaSUG,
November 2014, CDISC: The
Good, The Bad, The Standards
• Attendee, PhUSE Single Day
Event, April 2019, Disruptive
Technologies
• Attendee, Bay Area CDISC
Network April 2019, Submission
Standards
• Attendee, PINNACLE 21
Webinar, August 2019, Define's
New Style, 2018 Updates to xml
Stylesheet
SENIOR STATISTICAL PROGRAMMER
Zymeworks Biopharmaceuticals Seattle, WA Jan 2022 – May 2023
• Reviewed and contributed to the development of statistical analysis plans, TLF specifications, study CRFs, and database design specifications.
• Implemented and maintained programming standards and procedures for biometrics department, ensuring quality results.
• Used creative thinking and broad expertise to develop innovative and efficient programming solutions to analyze complex clinical trial data.
• Ensured compliance to CDISC and FDA standards for submitting data, programs, and analyses for regulatory submissions. EDUCATION
PRIOR CAREER EXPERIENCE
Ms. Collins former career used many skills akin to programming. As a mechanical engineering designer she possesses many skills applicable across career platforms. She excelled in project management roles and exercised her knowledge of engineering codes and engineering specifications and documentation. She also designed and created databases for internal purposes to track project metadata which interfaced with the company’s intranet (internal). PRIOR CAREER
PROJECTS
• Phase II Pools and Spas of the
Venetian Hotel, Las Vegas, NV
• The Boston Convention and
Exhibition Center, Boston, MA
• The M.I.T Ray and Maria Stata
Center, Cambridge, MA designed
by Frank Gehry Architects
• Others - Bose, Biogen, BlackRock,
Fidelity Investments
Contact this candidate