Senior Statistical Programmer 7+ Years in CDISC, SAS, SDTM/ADaM

Manthan Jha

**************@*****.***

California

Senior Statistical Programmer with 7+ years of experience supporting global clinical trials across multiple therapeutic areas including Oncology and Immunology. Skilled in SDTM and ADaM programming, CDISC standards, and regulatory submissions (CSR, ISS, ISE, DSUR). Experienced in compound-level data integration, QC, and development of submission-ready datasets. Adept at leading cross-functional programming activities and mentoring junior programmers.

Master of Public Health in Epidemiology and Biostatistics, NYU

Master of Technology – Bachelor of Technology (dual degree) in Biotechnology, Pune University, India

Pfizer, NJ June 2019 – Present

Senior Statistical Programmer

Worked as a SAS Programmer across multiple therapeutic areas including

Oncology, Rheumatoid Arthritis,Ulcerative Colitis, and Vaccines (COVID-19),

supporting both production and validation activities.Supported key regulatory deliverables such as Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), Investigator’s Brochure (IB), and DSUR in alignment with regulatory timelines.

Contributed to interim analyses, Blinded Data Review (BDR), Risk

Management Plans (RMP), Clinical Study Reports (CSR), and EU/BR safety

and efficacy submissions.

Reviewed output packages and performed edit checks to ensure accuracy,

consistency, and overall quality.

Generated Tables, Listings, and Figures (TLFs) from ADaM datasets in

compliance with CDISC standards using SAS 9.4 and SAS Studio.

Developed, updated, and reviewed SDTM submission packages, including

regulatory documents such as SDRG and ADRG, and supported define

specifications for submissions.

Created and reviewed SDTM-related documentation including P21 issue

summaries, CTC criteria, inclusion/exclusion criteria, screen failure details,

and related appendices.

Developed Trial Design datasets including TI (Trial Inclusion/Exclusion) and validated TA (Trial Arm), TE (Trial Element), and TV (Trial Visit) datasets.

Wrote SAS programs to identify screen failures and re-screened subjects

using both raw and post-processed SDTM and ADaM datasets.

Developed SAS macros to automate checklist generation and outputs in

formats such as Excel and CSV.

Reviewed protocols and aCRFs, developed SDTM specifications, and

performed SDTM mapping in accordance with CDISC SDTM IG v3.2.

Independently handled production and validation of ADaM datasets including ADAE, ADCM, ADMH, and ADRP, ensuring compliance with ADaM IG v1.0.

Supported production and validation of clinical summary tables and safety

listings as per SAPs and mock shells.

Performed descriptive statistical analyses using SAS procedures and

generated outputs in HTML and PDF formats

Maintained analysis dataset libraries, study documentation, and reusable

knowledge assets.

Supported ad hoc, post-ad hoc, and publication-related analysis requests as

needed.

Mentored interns and junior programmers on programming best practices and

CDISC standards.

Ensured clear, timely communication on project status, risks, and

implementation changes.

SynteractHCR Inc, NC Apr 2017 – June 2019

Statistical Programmer

Working for multiple studies in different stages of clinical trials. Working on various therapeutic areas including Oncology (like TR, TU, RS domains).

Generated specifications from scratch and generated analysis datasets

Works on the validation of annotated CRF for the creation and mapping of current or legacy studies for study and submission level activity.

Performed SDTM mapping using CDISC SDTM implementation guidelines various data sources/CRFs.

Performed QC and created study specific Edit Checks using various procedures. Statistical procedure used PROC FREQ, PROC MEANS, PROC COMPARE.

Successfully developed SAS programs to create different SDTM domains like DM, AE, DS, CM, LB etc.

Developed mapping Specification from all data sources including CRF data and external data according to applicable reference documents. Experience in working with different SDTM versions V 3.1.2, V 3.1.3, and V3.2.

Experience in the process of data reconciliation for domains involving the external data like AE and LB etc.

Performed QC on numerous studies by independent programming. Also, performed validation of data by using proc compare and Open CDISC tool (currently using v2.0 and v2.1). Experience in data quality and SDTM Compliance check, cross verification across domains.

Developed SAS programs for ADAM datasets like ADSL, ADTTE and ADAE etc. Also, creates table, listing and figures.

Working experience on SDTM Submission package for multiple studies, created Submission deliverables; from SDTM annotated CRF and controlled terminology to SDTM domains, SDTM validation documentations and SDTM Define (have experience on annotating blank CRF (Annotated Case Report Form), Controlled Terminology, Reviewer’s Guide).

Worked on developing Macros and updating already existing Macros according to raw data and project.

PROFESSIONAL SUMMARY

EDUCATION

PROFESSIONAL EXPERIENCE

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