Kamal C.

Kamal C.

ArlingtonMA

Certified Sr Statistical Programmer

Advance SAS certified programmer with over 15 years of experience working in big pharma and CROs, leading projects for clinical trial for FDA submission following CDISC standards for SDTMs (v3.3) and ADaMs (ADaM v2.1 & ADaMIG v1.1) and manuscripts for research based patient registries and large insurance data claim. Therapeutic areas : oncology - evaluating reduction in tumor size of experimental compound neurology - assessing efficacy of new compound in reduction of depression severity/suicidal tendencies based on Columbia-Suicide Severity Rating Scale (C-SSRS), Bech-6 Score, Santen-7 Score, Summary of the HDRS-17 Score. Dermatology- topical cream evaluation. Kidney disease . Respiratory- using Wisconsin Upper Respiratory Symptom Survey Results(WURSS) ADaMs: ADSL, ADEX, ADAE, ADLB, ADVS, ADCM, ADEG, ADMH, ADQS, ADPD, ADPK, ADTTE, ADRS,ADTU STDMs: DM, SE, SV, CM, EC ,EX, SU, PR, AE, DS, DV ,MH, CM, MH, EG, IE VS ,LB, QS, RS, TR, TU. Tables: Change from Baseline Summary Tables AE Tables Lab abnormalities Develop statistical Macro programs to generate multiple tables, listings with one program. Ensure that regulatory requirements are met through validation/compliance activities. Native bilingual English/ French speaker who is also experienced in translating procedures, technical and articles from french into English or English into French. Develop PowerBi dashboard to track study metrics.
No items

Skills

  • ADAM Software ADAM
  • SQL Programming
  • Statistical Analysis
  • Statistical Programming
  • SAS
Kamal C.

Kamal C.

ArlingtonMA
6
Total Jobs
38
Total Hours

Certified Sr Statistical Programmer

Specializes in
Advance SAS certified programmer with over 15 years of experience working in big pharma and CROs, leading projects for clinical trial for FDA submission following CDISC standards for SDTMs (v3.3) and ADaMs (ADaM v2.1 & ADaMIG v1.1) and manuscripts for research based patient registries and large insurance data claim. Therapeutic areas : oncology - evaluating reduction in tumor size of experimental compound neurology - assessing efficacy of new compound in reduction of depression severity/suicidal tendencies based on Columbia-Suicide Severity Rating Scale (C-SSRS), Bech-6 Score, Santen-7 Score, Summary of the HDRS-17 Score. Dermatology- topical cream evaluation. Kidney disease . Respiratory- using Wisconsin Upper Respiratory Symptom Survey Results(WURSS) ADaMs: ADSL, ADEX, ADAE, ADLB, ADVS, ADCM, ADEG, ADMH, ADQS, ADPD, ADPK, ADTTE, ADRS,ADTU STDMs: DM, SE, SV, CM, EC ,EX, SU, PR, AE, DS, DV ,MH, CM, MH, EG, IE VS ,LB, QS, RS, TR, TU. Tables: Change from Baseline Summary Tables AE Tables Lab abnormalities Develop statistical Macro programs to generate multiple tables, listings with one program. Ensure that regulatory requirements are met through validation/compliance activities. Native bilingual English/ French speaker who is also experienced in translating procedures, technical and articles from french into English or English into French. Develop PowerBi dashboard to track study metrics.
No items

Skills

  • ADAM Software ADAM
  • SQL Programming
  • Statistical Analysis
  • Statistical Programming
  • SAS
Less than 30 hrs/week