SALINI RADHAKRISHNAN

Dynamic SAS programmer with more than14 years of experience excelling in operations and project management. Proven track record in various therapeutic areas and different phases of the studies. Expert in all aspects of clinical study programming, with strong leadership qualities and team collaboration.

• Certified SAS/Statistical Programmer with experience in programming, analyzing, and reporting Clinical
  Trials data.
• Experience as a Lead Programmer overseeing the work of CROs or FSPs.
• Skilled in various SAS modules including Base SAS; Advanced SAS, SAS/Macros, SAS/GRAPH, SAS/ODS, SAS/SQL, and
  SAS/Report.
• Possess knowledge of the drug discovery process and clinical trial phases, as well as well-versed in ICH-GCP, GPP, and 21-CFR
  Part 11 regulations.
• Familiar with essential Clinical Trials documents including Study Protocol, Case Report Form (CRF), and Statistical Analysis
  Plan (SAP).
• Capable of defining/writing and debugging SAS Macro programs.
• Skilled in annotating CRF (aCRF) fields using SDTMIG standards.
• Experienced in writing specification, generating and validating CDISC datasets (SDTM, ADaM) and TLFs, both standard and
  customized. Also, worked on subgroup analyses for publications, ad-hoc reports.
• Experienced in utilizing diverse SAS procedures such as Proc Report, Proc Summary, Proc Freq, Proc Mean, Proc
  Transpose, Proc Sort and Proc SQL, Proc Univariate, Proc Tabulate, Proc Import, Proc Copy, Proc Export, Proc Gplot,
  Proc Gchart, Proc Compare, Proc Lifetest, Proc GLM and others for data manipulation and analysis.
• Proficient in validating CDISC datasets using tools like Pinnacle21 community and Enterprise versions and generating associated reports.
• Excellent understanding of the Bio-statistical workflow starting from Raw Datasets to submission package creation (writing
  Define specs, creating SDRG/ADRG and generating Define.XML).
• Utilized SAS on various platforms like UNIX, Entimice, Gitlab
• Languages: SAS, SQL, R (SAS Studio, SAS 9.4, SAS Enterprise Guide and R Studio)

SAS Certified Specialist: Base Programming Using SAS 9.4

University Rank Holder (III) in BSc Statistics from MG University in the academic year of 2004- 2007.

Base SAS Certification.

IQVIA awards for Trainings and Projects Deliveries (5 in number).

ICON awards for Trainings and Projects Deliveries (6 in number).

Navitas award for Trainings and Project Management(2 Number).

Attended the PHUSE Conference on "Achieving Efficacy in Programming, Analysis, and Reporting of New Age Clinical Trials," gaining insights into the latest trends, best practices, and innovative approaches in clinical trial programming and reporting (11/2024) PHUSE SDE, India

Attended the PHUSE Conference on "Industry 4.0: Avoiding Digitization and Modernization 'Not an Option'," where I gained valuable insights into the impact of digital transformation on clinical trials, focusing on the importance of modernization in programming, analysis, and reporting. (07/2019)