Hi, I’m
Shrijal Patel
Calgary,AB
Summary
Focused professional with nearly 9 years of experience, 2.7 year as a CQA officer and 6 year as a SAS Programmer,including leadership roles in complex projects. Skilled in project management, statistical programming techniques, and client relationship management. Proven track record of delivering high-quality deliverables on time and earning client trust.
Overview
9
years of professional experience
1
Certification
Work History
Cliantha Research Limited
Sr.Statistical Programmer II
04.2022 - 01.2024
Job overview
- Lead a team of 20 programmers for late-phase studies, overseeing project progress and personnel management
- Successfully resolved complex statistical programming issues and ensured timely delivery of high-quality deliverables
- Represented the company in client interactions, bid defense meetings, and regulatory agency interactions
- Provided training, mentorship, and technical guidance to less experienced Statistical Programmers
- Developed and reviewed TLFs, SDTM, and ADaM dataset specifications, ensuring adherence to efficacy requirements and performed quality control reviews
- Developed ISS, and ISE following company's or client's Standard Operating Procedures (SOPs) and project-specific requirements
- Led programming teams in support of product regulatory submission activities and performed quality assessments on regulatory submission documents
- Maintained expertise in utilities and macros developed for Statistical Programmers and developed new macros and utilities as needed
- Ensured compliance with corporate SOPs and guidelines, documented data and programming information, and archived clinical trial data in accordance with corporate archival SOPs.
Cliantha Research Limited
Executive
03.2021 - 03.2022
Job overview
- Developed and reviewed Statistical programs to create the analysis data set, table, listing and figure of clinical study
- Perform the validation of the programs used for analysis of statistical and non-statistical data
- Write and revise SOPs as per need to maintain awareness and adherence to all current SOPs
- Maintain all necessary records for the reporting phase of the study
- Review and provide necessary input in database design template Developed and reviewed code for other related activities and transformed raw data to CDISC-SDTM & ADaM standards
- Establish monitoring of data transfers for ongoing trials to identify data quality issues
- Review eCRF, SAP and mock shell with programming perspective.
Lambda Therapeutics Research Ltd
Technical Associate
06.2018 - 02.2021
Job overview
- Generated tables and listings for over 30+ projects mostly CT Projects
- Including efficacy tables
- Resolved data related issues for CDM team Preparation of SAP
- Modified programs to simplify processes and created custom reports as per laboratory requirements.Created custom reports as per laboratory requirement Acquired through knowledge of CDISC SDTM and ADaM Guidelines.
Otsuka Pharmaceuticals, Previously known as Claris Otsuka
CQA-Officer
02.2015 - 10.2017
Job overview
- Preparing, Issuing, Managing and Reviewing 600+ plant SOPs of various department like Quality Control, Quality Assurance, Production etc Used to conduct and give training to the relevant department while SOP upgradation and gave training to new joiners of various departments on weekly bases
- Generating, Reviewing and Releasing 2000+ Artworks yearly (Using SAP (M Module)) Generating GTIN Bar-codes Proficient in MS Office Tools
Education
Epoch Research InstituteAhmedabad, Inida,
SAS/BASE, Macro, SQL, Report, and Graph certification
01.2018
KLE College of PharmacyBangalore, India
B Pharm
01.2013
Skills
- Extensive experience in SAS programming, including SAS/BASE, SAS/MACRO, SAS/SQL, and SAS/ODS
- Strong project management skills, with the ability to lead projects with high complexity and challenges
- Excellent communication and interpersonal skills, with experience representing the company in client interactions and bid defense meetings
- Proficient in developing and reviewing SDTM and ADaM dataset specifications and performing quality control reviews manipulating the data to produce analysis datasets
- Proficient in developing and reviewing of Tables, Figures and Listings (TFLs) according to statistical analysis plan and validating efficacy and lab data
- Experienced in mentoring and providing technical guidance to junior team members
- Proficient in CDISC standards and resolving regulatory queries
- Trained in various data management skills like merging, handling missing values, reading raw data files, creating data structures, handling data errors, accessing and managing data, appending concatenating, Interleaving of SAS data sets, and generating efficacy tables
Cover Letter
Dear Hiring Manager,I am writing to express my keen interest in the Senior Statistical Programmer position at PHASTAR as advertised. With a solid academic background and extensive hands-on experience in Clinical SAS Programming, I am excited about the opportunity to contribute to your organization's growth and success.Throughout my career, I have consistently demonstrated a commitment to excellence, adhering to Standard Operating Procedures (SOPs) and successfully tackling various challenges in clinical studies. As a seasoned Statistical Programmer, I have led teams of up to 20 programmers, ensuring project adherence to regulatory compliance and ethical standards. My experience spans Phase I-IV clinical studies, where proficiently I have created and validated TLFS, CDISC datasets and documents, and handled data cleaning and edit checks with meticulous attention to detail.In addition to my technical expertise, I pride myself on my effective communication skills and ability to foster positive relationships with cross-functional teams. By maintaining a collaborative and supportive work environment, I have consistently delivered high-quality results, even under tight deadlines.I am particularly drawn to the reputation of PHASTAR for the excellence in clinical research and its commitment to innovation. I am eager to bring my skills and experiences to your esteemed organization, contributing to its continued success.Thank you for considering my application. I am enthusiastic about the possibility of joining your team and am available for an interview at your earliest convenience. Please find my resume attached for your review.Yours sincerely,Shrijal Patel
Personal Information
Title: Senior Statistical Programmer
Languages
English
Native or Bilingual
Hindi
Native or Bilingual
Gujarati
Native or Bilingual
Certification
SAS Certified.
Timeline
Sr.Statistical Programmer II
Cliantha Research Limited
04.2022 - 01.2024
Executive
Cliantha Research Limited
03.2021 - 03.2022
Technical Associate
Lambda Therapeutics Research Ltd
06.2018 - 02.2021
CQA-Officer
Otsuka Pharmaceuticals, Previously known as Claris Otsuka
02.2015 - 10.2017
Epoch Research Institute
SAS/BASE, Macro, SQL, Report, and Graph certification
KLE College of Pharmacy
B Pharm
SAS Certified.
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