Profile

Senior Statistical Programmer/Study Lead with over 13 years of experience in analyzing clinical trials data

Proficient in analysis and reporting of clinical trials (Phase I-Phase III) data.

Extensive work experience in SAS. SAS-Base, SAS-MACROS; select procedures of SAS-STAT, SAS-GRAPH

Thorough working knowledge of several therapeutic areas - Central Nervous System, Chronic Obstructive Pulmonary Disease, Diabetes, Virology, Oncology

Successful handling of various submissions for FDA, EMEA, Japanese Regulatory agencies

Created Specs and developed Efficacy datasets and TLGs as per therapeutic area standards for CNS, COPD, Diabetes

Created Specs and developed analysis data and TLGs for Safety domains like Demography, Lab data, Exposure, Adverse, Concomitant medication, Vital signs, ECG and other standard safety data.

Created non-standard datasets and TLGs for additional efficacy analysis like Questionnaires data, Patient Diary data and Gene sequencing data for exploratory analysis.

Efficacy Analysis for TLGs for Oncology- Survival analysis, sensitivity analysis and other statistical analyses as required by study.

Involved in database locks, unblinding and complete reporting of the study as per SLA of the company.

Involved in Post study submission – Additional analysis, Exploratory analysis, Ad-hoc requests

Worked on Integrated Summary of Efficacy of Diabetes study pooling 5 different studies

Leading programming team (team size 10-12) working on different studies and different submissions of same TA while taking up programming of the complex portions of the study

Experience of leading teams in matrix structure

Familiarity with CDISC/ ADaM standards

Work Experience

March2015 – Jul2017 with Sciformix Technologies, Mumbai, India as Sr. Statistical Programmer (Project Manager) for Parexel client- Pfizer

Responsibilities:

Project: Oncology study: 2 different molecules, multiple studies

These projects were on client in-house reporting system consisting of in-built macros

Led team of programmers on two studies BDR safety reporting especially AE, Exposure & Labs

Acted as internal SME for reporting system setting-up and table generation.

Wrote SAS validation programs for critical tables

Simultaneously involved in regular safety submissions of other oncology studies

Crosscheck consistency between reports and with datasets & SAP

Accountable for complete set and overall quality of the deliverables

Proactively raise data queries and any other programming issues with client

Act as link between in-house programming team and client side -Study statistician and programming lead

Other Responsibilities

Track productivity, resource utilization, resource estimation and allocation for existing and upcoming projects

Manage team of programmers with regular meetings, refining the KRAs & regular appraisals

July2012 – Mar2015 with Sciformix Technologies, Mumbai, India as SAS Consultant

for Parexel client- Pfizer

Responsibilities:

Project1: Diabetes Neuropathic Pain

Complete programming of Efficacy submission of Diabetes Neuropathic Pain study

oDeveloped programs for many efficacy datasets including Patient Diary data and Questionnaire data and Efficacy Tables.

oValidated programs for other efficacy datasets and Tables

oProactively raise data queries and any other programming issues with client

for efficacy reporting

Project2: Oncology study

Successfully led a team of 10 programmers of a SLC carcinoma study from review of Specs, Development and Validation of Safety analysis data, complete study safety and efficacy reporting of close to 500 reports. Involved from regular safety submissions, DMC and complete CSR for around two years.

oDeveloped and validated multiple analysis datasets and Tables

oValidated critical analysis dataset, tables and graphs

oPost study submission- Additional analysis, Patient profile

oCrosschecking of consistency between reports and with datasets & SAP

o Accountable for overall quality of the deliverables

oReview Table shells and raise queries/request updates as per SAP, CRF & Protocol

oProactively raise data queries and any other programming issues with client

oAct as link between in-house programming team and client side -Study statistician and programming lead

oConduct regular project update meetings with external and internal stakeholders

Apr2009 – June 2012 with Bristol Myers Squibb as Principal Analyst-I (Global Biometrics Sciences)

Responsibilities:

Develop TLGs for multiple studies in the assigned therapeutic area (Virology)

Writing SAS codes for validation of safety reports

Complete safety reporting and un-blinding of study for CSR submission for Japanese regulatory agency

Independent review of complete set of safety reports of a study in different therapeutic area

Involved in review of CRF for upcoming study

Line management for small group of programmers in Matrix team setup

Goal setting and appraisals of team members

Oct2007– Apr2009 with Tata Consultancy Services, Mumbai, India as Assistant Manager (Statistician)

for Novo-Nordisk, client of TCS

Responsibilities:

Project: Diabetes study for EMEA & US FDA

Study Lead for Integrated Summary of Efficacy

Write SAS programs to generate statistical Tables for integrated efficacy analysis

Write SAS programs to generate graphs for integrated submission

Worked on multiple Ad hoc requests post-submission

Write study specific Statistical Analysis Plans for another Diabetes study.

Write SAS code to check consistency of Raw data as it is loaded

Programming for efficacy reporting for analysis datasets and TLFs

Overall responsibility of complete project delivery including safety reports

Review of Clinical Study Report and input to statistical portion of the CSR

Oct2000– Dec2004 with Pfizer India, Mumbai as Sr. Statistical Programmer

Responsibilities:

Therapeutic Areas: CNS, COPD, multiple Phase-I studies

Write SAS programs to produce complete set of efficacy dataset and tables for CNS study.

Write SAS codes for Ad-hoc request from clinicians

Study set-up and Table generation for Phase-I clinical trials on in- house reporting system

Perform quality checks of the safety tables generated for study report.

Perform QC documentation for the study.

Lead and Supervise the programming & reporting for early development projects

Prepare TLG specifications, dataset specifications for COPD study

Write SAS codes for efficacy programming of COPD study.

Setting objectives, performance appraisal and development plans for team members

Other Experiences:

Apr2000– Sep2000 with Indian Cancer Society, Mumbai, India as Biostatistician

Responsibilities:

Statistical summarization of Bombay Cancer Registry data.

Overview of coding of data collected.

Periodic overview of collection of data

Feb1999– Mar2000 with Training Institutes LCC Computers, ET& T Computers, Bhilai (C.G.), India as Faculty Member

Responsibilities:

Teaching programming languages as C, C++ to multiple batches of students of high-schoolers & undergraduate students.

Academic Qualifications

Masters degree in Statistics, Pt. Ravishankar Shukla University, Raipur, C.G. India 1998

Bachelors degree in Maths, Pt. Ravishankar Shukla University, Raipur, C.G. India 1996

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