Rohit

Senior Statistical Programmer

TECHNICAL SUMMARY:

Sr. Statistical Programmer with around 9 years of experience in design, analysis, program development and Quality Check (QC) validation in Pharmaceutical and Clinical Research Organizations.

Extensive working knowledge in handling complex transformations using Base/SAS, SAS/STAT, SAS/Macros, SAS/SQL and SAS/GRAPH.

Work as Lead Programmer on one or more projects.

Hands on working experience in Phase I-III of clinical trials and various therapeutic areas including Oncology.

Ample knowledge and hands on experience in CDISC guidelines while producing SDTM and ADaM datasets, Tables, listing and Figures.

Experience in reviewing study documents- protocol, statistical analysis plan, mock shells, annotated CRF and SDTM and ADaM dataset specifications.

Experience in creation of annotated CRF with SDTM variables.

Created and reviewed SDTM mapping and ADaM specifications.

Good command in producing Integrated Summaries of Efficacy (ISE) and Safety (ISS).

Involved in FDA submissions and developed numerous Ad Hoc reports as required by medical writers and FDA.

Proficient in using SAS/ODS to create Ad-hoc RTF, PDF and Listing output reports.

Involved in SAS edit check programming for Data Management.

Created new macros and also modified existing macros as per the requirement.

Quick learner with ability to understand job requirements employs new ideas, concepts, methods, and technologies.

Strong analytical, diagnostic skills and ability to work in a fast-paced and team- oriented environment.

PROFESSIONAL SYNOPSIS:

Currently working with Ferring Pharmaceutical Inc as Senior Statistical programmer in New Jersey, USA

Assets

Abilities in managing time efficiently and effectively through scheduling and prioritizing.

Enjoy working in a multi-cultural, fast paced and simulating environment.

Good listener and quick learner with strong interpersonal and analytical skills.

TECHNICAL KNOWLEDGE

SAS Skill Set:

SAS/Base (Macros including SQL)

SAS/Graph

SAS/Access

SAS/Stat

SDD 4.5

Senior Statistical Programmer Sep’17 – Till Date.

Ferring Pharmaceutical

Parsippany, NJ

Role:

Provide statistical programming support to clinical trials for regulatory submissions and publications, and ad hoc or post hoc analyses.

Function as lead programmer on single or more projects and participate in project team meetings.

Assume protocol level responsibilities in statistical programming. Review protocol and SAP, write/review analysis data specifications, etc. Interact with Statisticians, Clinical Data Programmers, Data Managers,

Personnel and project manager to ensure the timeline and quality of analysis data and reporting.

Including in writing the SAS programs for derived datasets, CDISC Adam datasets, tables, figures and listings and program validation.

Ensure the maintenance and supporting the documentation like the description of programs and validation and also define.xml for clinical studies.

Independently validate SAS data sets and outputs from CROs or other programmers.

Provide project support to the statistics reporting process through the specification of tables, figures and listings shells, writing of derived dataset specifications and the formatting of report documents

Participate in the company's development of SOP and implementation of global analysis data standards, output formats, standard SAS programs, etc.

Maintain and test the in-house programming standards in line with the quality standards and regulations.

Lead role in identifying system and process improvements, and to develop and implement solutions to improve the efficiency and quality of clinical study data processing and reporting.

Working on therapeutic areas like: Oncology, Gastroenterology, Urology, Reproductive Medicine & Women's Health.

Pooling of trials and Providing inputs for DSUR, PSUR

Mentor and Train new programmers on Ferring SOP, SAS knowledge and peer review their deliverables.

Development of Patient profiles/Subject level Listings.

Involved in meetings for DataBase lock, Medical Monitoring.

Point of contact for other programming teams across different geographic locations.

Involve in the testing of the ePRO devices (electronic patient-reported outcome).

Statistical Programmer Sep’13 to Aug’17.

Ferring Pharmaceutical

DENMARK and INDIA

Role:

Leading trials with ref. to statistical programming along with a team and coordinating

with the other stalk holders at client site for submission purpose.

Leading trials with ref. to statistical programming along with a small team and coordinating with

Developed programs to generate/Validate ADaMs, TLF and Analysis datasets,

Involved in meetings for DataBase lock, Medical Monitoring.

Created TLF for adhoc request for both global and client standards.

Development/Testing of Client standard Macros as requirements.

Assisted in the creation of the submission package.

Stilities development for optimization of Process workflow.

Clinical SAS Programmer Mar’11 to Aug’13.

Pfizer

INDIA

Role:

Extensively using Base SAS and Macros to map and analyze Client's Data into Client's format.

Mapping data from different standards to client specific data standards using

client’s internal tools based on SAS.

Actively participating in process improvement drives.

Producing nearly defect-free output by doing quality coding and review.

Coding and generating reports in SAS to analyze and verify the mapped data.

Running and analyzing the Quality Gate reports to meet the requirements

ACADEMIC CREDENTIALS:

B. TECH (Computer Science) from UPTU, UP 2006-10. (Secured 1st Division)

INTERNATIONAL CERTIFICATIONS

SAS Advance Programming Certification from SAS Institute Inc.

SAS Base Programming Certification from SAS Institute Inc.

PERSONAL DOSSIER:

Languages: English, Hindi

Present Address: Parsippany, New Jersey, 07054

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