Anitha Priyadharshini
Lead Statistical Programmer
Chennai
Summary
With over 10 years of experience in sas programming and analysis, I specialize in SDTM, ADaM, TLFs, SAS, and R, with a particular focus on safety and efficacy analysis.
- Clinical Data Management: Proficient in converting raw clinical trial data into SDTM and ADaM datasets, ensuring data integrity and regulatory compliance.
- Programming Skills: Skilled in SAS and R programming, developing complex TLFs for clinical study reports, regulatory submissions, and data visualization. Advanced knowledge includes SAS macros, SQL, and R for efficient data processing and analysis.
- Safety Analysis: Experienced in adverse event (AE) analysis, SAE reconciliation, and generating safety tables and listings. Skilled in detecting safety trends and signals.
- Efficacy Analysis: Proficient in efficacy endpoint analysis, including response rates, survival curves, and time-to-event analyses. Experienced in assessing treatment effects and summarizing key findings.
- Regulatory Compliance: Well-versed in regulatory guidelines (ICH Efficacy and Safety), ensuring analyses meet regulatory requirements for ISS/ISE submissions.
- Data Interpretation and Communication: Skilled in interpreting and presenting complex clinical data to cross-functional teams and stakeholders.
- Peer Review and Attention to Detail: Known for meticulous attention to detail, leading peer review processes to ensure accuracy and quality of analyses. Consistently identify and resolve discrepancies, ensuring data integrity and reliability.
- Therapeutic Areas: Extensive experience across various therapeutic areas,
o Parkinsons's - Neurology
o Diabetes - Endocrinology
o Crohn's disease - Gastrointestinal
o Virology - Infectious
o Breast Cancer, Solid Tumors, Tumor Diagnostics, Bladder Cancer - Oncology
o Vaccines – Treatment
o Hepatitis, Bacterial Infection – Infectious
o Multiple System Atrophy – Neurology
o Epilepsy – Neurology
- Quality Focus: Committed to delivering accurate, timely, and insightful analyses to support informed decision-making in drug development.
Overview
17
17
years of professional experience
7
7
years of post-secondary education
1
1
Certification
Work History
Lead Statistical Programmer
Algorics
12.2022 - Current
- Perform end-end project activities including creation of dataset specifications, development, and validation of datasets (SDTM & ADaM) and TLFs
- Design macros and reusable code for repetitive tasks and improve efficiencies.
- Develop define.xml, annotated CRF and reviewer guides for SDTM and ADaM
- Participate in client calls and communicate regular status updates to project lead/client and highlight issues, as necessary.
- Follow client and/or internal SOPs and produce high quality deliverables.
- Mentor junior programmers – guide them in subject matter and help them out with programming issue.
- Participate in internal trainings and improve and add on to skill set.
- Involve in project estimates and planning.
- Enhanced collaboration between statisticians and programmers through regular knowledge-sharing workshops and presentations.
- Evaluated reliability of source information by weighing raw data to make data easier to interpret.
- Provided training sessions on statistical software packages, increasing team proficiency and productivity.
- Contributed to successful clinical trial outcomes by delivering accurate and timely statistical analyses.
- Conducted quality checks on data sources to check for inconsistencies and perform data cleaning activities.
- Developed data tables and databases to create relation between tables to allow efficient data retrieval.
- Ensured regulatory compliance with FDA guidelines, maintaining strict adherence to industry standards.
Senior Statistical Programmer
ICON Clinical Research
04.2019 - 11.2022
- Worked as an independent programmer handling FSP portfolio, for ADaM and TLG submissions
- Created ADaM specifications, datasets and TLFs based on SAP
- Interacted with statisticians, data managers and maintained issue log actively
- Reviewed SDTM specification and worked as Unblinded Programmer for blinded studies
- Created and validated Immuno-subset groups to determine sampling data for blood draw
- Analyzed Protocol deviation and Quality Tolerance Limit at start, during and end of study
- Involved in various initiatives for team building, knowledge/JAM sessions and mentoring juniors.
- Conducted thorough peer reviews of colleagues'' work to ensure accuracy, consistency, and adherence to established standards.
- Served as mentor for junior team members, providing guidance and support in development of their programming skills and career growth.
Programmer Analyst
Zifo RnD Solutions
02.2015 - 04.2019
- Worked as analyst and developed/validated SDTM, ADaM and TLFs as per study requirement
- Created aCRF, SDRG for submissions.
- Created macros for study-specific needs and validated them.
- Worked as full time FSP and handled client calls and updated team on proceedings.
- Communicated complex technical concepts clearly to non-technical stakeholders during project discussions and progress updates.
- Mentored junior developers on best practices, helping them grow their skill sets while enhancing overall team capabilities.
- Contributed to successful project completion with effective time management and prioritization skills, meeting tight deadlines consistently.
- Updated documentation with project deviations to capture changes.
SAS trainee
Xertz SAS Institute
02.2014 - 02.2015
- Worked as SAS trainee and handled various small-scale projects and assisted in project delivery.
- Learned new materials, processes, and programs quickly.
- Participated in a research project on epidemiology analysis related to mosquitoes.
- Conducted data analysis and interpretation using SAS to identify patterns and trends in disease transmission.
Process Lead
Thomson Scientific
Chennai
06.2007 - 11.2008
- Evaluated process performance metrics, identifying areas requiring improvement or optimization for increased efficiency.
- Mentored junior team members, providing guidance on best practices and contributing to their professional development.
- Reviewed production schedules and streamlined processes.
- Managed quality assurance initiatives.
- Managed teams effectively, fostering an environment of open communication and collaboration for better overall performance.
- Managed team of 14, and was POC for UK HUB business unit, for editorial operations.
Education
Master of Science - Medicinal And Pharmaceutical Chemistry
VIT UNIVERSITY
Vellore 01.2005 - 04.2007
B.Tech. -
VIT UNIVERSITY
Vellore 01.2001 - 04.2005
Advanced Diploma - Clinical Research And Pharmacovigilance
Cliniminds
IndiaSkills
Data Cleaning
undefinedConfidential
True
Revision History
The CV is updated by using the new template.
Page
3, 3
Certification
BASE SAS certification
Timeline
Lead Statistical Programmer
Algorics
12.2022 - Current
BASE SAS certification
11-2020
Senior Statistical Programmer
ICON Clinical Research
04.2019 - 11.2022
Programmer Analyst
Zifo RnD Solutions
02.2015 - 04.2019
SAS trainee
Xertz SAS Institute
02.2014 - 02.2015
Process Lead
Thomson Scientific
06.2007 - 11.2008
Master of Science - Medicinal And Pharmaceutical Chemistry
VIT UNIVERSITY
01.2005 - 04.2007
B.Tech. -
VIT UNIVERSITY
01.2001 - 04.2005
Advanced Diploma - Clinical Research And Pharmacovigilance
Cliniminds
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