Zafrulla Khan

SAS certified Principal Statistical programmer with 10 years of programming experience in pharmaceutical industry in various therapeutic areas. Focused commitment towards quality deliverables on time. Expertise and knowledge of CDISC implementation for SDTMs and ADaMs, drafting/reviewing specifications, production, QC and review of SDTM and ADaM datasets, TLFs and P21 checks. Programmed, QCed and reviewed CDISC datasets and TFLs for various study deliverables such as CSR, IA, & DMCs.

Experience in integrated datasets and TLFs for Integrated summary of safety (ISS). Regulatory submission experience in creation and review of Define.xml, cSDRG, and ADRG. Worked on challenging and quick turnaround adhoc requests for publications and RTQs for various regulatory authorities like FDA, PMDA, & EMA.

Creation of SAS macros at study level for datasets, validations and TLF report generation and other requirements. Work experience with various therapeutic areas such as Vaccines, Rare diseases, Oncology, Cardiovascular, Respiratory, and device studies. Thorough knowledge and understanding and implementation of RECIST concepts.

Ability to understand requirements and work independently or integrated into teams. Good communication skills, project management skills, and problem-solving skills.

Senior/Principal Statistical Programmer - Takeda

(2022-06)

Working as a co-lead with responsibilities including task assignment, tracking, issue management, review of comments, tracking data issues, protocol/SAP guidelines, mock shell drafting/updates, define XML/P21 review, ensuring deliverables quality. Other study level activities include reviewing TLFs data & numbers, creating pdf bundles of reports, datacutoff management, and version control of code.

• Assigning & tracking tasks, issues log, review and updates of comments from stats
• Tracking data issues, Protocol/SAP guidelines, Mock shell drafting/updates and review
• Define XML/P21, ensure deliverables quality on time, aCRF, specs writing & review of SDTMs & ADaMs
• Submission activities, SDTMs, ADaMs, TLF production and validation
• Reviewing/checking the TLFs data & numbers, comparisons, creating pdf bundles of reports, datacutoff
• Ensuring version control of code
• Creating study level macros, using, modifying, or updating standard macros for TLFs
• Drafting, updating or reviewing specs for SDTMs & ADaMs
• Production or QC of SDTMs and ADaM datasets, TLFs for Safety and Efficacy
• Worked on various adhoc requirements for FDA, PMDA, & EMA
• Updating of SDTMs and ADaMs datasets based on the issues of P21
• Interaction with peers, Biostatisticians, data managers, medical writers, point of contact to clarify requirements, escalate issues

Senior Statistical Programmer - Amgen

(2020-01 - 2022-02)

• Worked on datasets and baseline, safety, and efficacy TLFs for phase II and III clinical trials
• Drafted/reviewed SDTM and ADAM Specifications in accordance with protocol and SAP, mock shells and CDISC implementation guidelines
• Production and QC for SDTMs, ADaMs, TLFs for phase II and III studies
• Back-up lead programmer and project management for assigned studies – participating clinical study team meetings, providing input for timelines, tracking programming status, providing support to study programmers, and performing documentation requirements
• Involved in submission activities including preparing programs, review of define xml, draft parts of cSDRG and ADRG documents
• Validate SDTM and ADaMs datasets using CDISC open compliance checks/P21, spot check and independent parallel programming
• Programmed efficacy ADaM datasets and TFLs for Oncology study based on RECIST1.1 criteria
• Created efficacy summary tables related to primary endpoints like Overall Survival, Progression Free Survival, Objective Response Rate, and KM graphical plots
• Interact with peers, Biostatistician, Data managers, medical writers, point of contacts to clarify requirements, escalate issues, and perform sponsor oversight activities
• Review and provide input for study-related documents produced by other functions like SAP, Mock TFL shells, CRF, data management plan, database specifications and other documents
• Mentoring other stats programmers to understand study requirements and provide input to review study documents
• Drafted, maintained, and updated specific documents and tracking files such as programming plan, project tracking file, issue log and other study specific documentation

Senior Statistical Programmer - Gilead Sciences

(2018-08 - 2020-01)

• Generation datasets, baseline and safety tables, listings and figures included in Clinical Study Reports, DSUR, SRT, ASCO publications for phase II and III clinical trials
• Production and QC of SDTM and ADaM datasets and drafting specifications
• Programmed efficacy ADaM datasets and TFLs for Oncology (RECIST1.1) study for primary endpoint of Overall Complete Remission Rate, and for secondary endpoints like Duration of Remission, Overall Survival
• Performed raw data review and escalate data issues to Data Management and keep track of resolution for those
• Review and provide input for clinical study documents CRFs, SAP and mock shells
• Created and used generic macros for report generation and re-usable code fragments
• Involved in programming of ADaMs and TFLs for ISS
• Developed and validated specifications for SDTM and ADaM datasets for those studies
• Created ad-hoc deliverables for internal and external quick turnaround ad-hoc requests
• Programmed summary tables and listings for Demographics, Screening failures, Disposition, Concomitant medication, Period disease history, protocol deviations, Prior Anti-cancer therapies, dose compliance tables, AE summary Tables, Vital signs, ECG, Laboratory summary and Shift Tables

Senior Statistical Programmer - Novartis

(2016-10 - 2018-07)

• Generated Tables Listings and Graphs for assigned clinical studies and performed statistical analysis on the clinical data as per SAP and mock TFL shells
• Worked on production and qc of SDTM datasets
• Created analysis datasets based on the guidelines provided in the data definition tables (DDT)
• Validated analysis data sets and other outputs based on study specifications and applicable validation SOPs, and CDISC standards
• Produced and validated statistical summary outputs for primary and secondary end points using model provided by statisticians using procedures
• Involved in submission activities like P21 compliance checks, updating ADRG, and review of define.xml
• Maintained and updated study documentation such as qc forms, project tracker, and issue log
• Escalated data issues to Data management and kept a log of their resolution

Statistical Programmer - Boston Scientific

(2016-04 - 2016-09)

• Worked on production and validation of various non-CDISC Analysis datasets and Tables, Listings and Graphs on device studies
• Worked on subgroup analysis TFLs
• Creation and review of define document
• Worked on dairy medications data
• Created analysis dataset specifications based on protocol, and statistical analysis plan, TFL shells
• Created combined RTF file from all TFLs generated
• Worked closely with biostatisticians on various projects in generating study specific tables, listing, graphs, and reports

Java and SAS Developer

(2010-01 - 2016-03)

Master of Computer Applications - Computer Applications - Bangalore University (2005)

Bachelor of Computer Applications - Computer Applications - Andhra University (2001)