Open Positions

Statistical Programmer II

General Responsibilities

  • Work closely with project manager and biostatistician, data management team, assist in reviewing statistical analysis plan (SAP), study protocol, annotated CRFs, and analysis file specifications, etc, provide high quality statistical programming support for clinical trial projects. 
  •  Develop and validate complex SAS programs, SAS macros to create tables, listings and graphs (TLGs), generate and validate SDTM and ADaM datasets for multiple phase I- V studies, as well as integrated Summary of Safety and Efficacy (ISS/ISE) for FDA submission, and provide SAS programming specifications for CDISC SDTM and ADaM datasets, including proper validation, testing and documentation. 
  •  Develop and validate SAS programs for collecting, processing, analyzing and interpreting safety and efficacy data that are collected during clinical trials. 
  • Perform high quality statistical analyses and technical support for the clinical trial studies using various statistical procedures, statistical theory and SAS/STAT/MACRO/GRAPH /SQL techniques. 
  • Gather, manipulate, interpret and report safety and efficacy data that are collected during clinical trials, review data collection and management methodology and assure acceptability and scientific integrity of data collection and analysis through appropriate application of statistical methodology and principles of probability.
  • Use statistical techniques to analyze the clinical data and generate Ad-hoc safety summary reports for review by research scientists and medical directors. Also be responsible for checking whether the data are out of range of any safety guidelines provided by FDA or other 
  • agencies, communicate with project manager and notify client Alnylam Pharmaceuticals, Inc in a timely manner on any abnormal testing results.  
  • Participate in preparing clinical study results for FDA submissions using SAS; writing intense QC documentation for every stage of reporting from extraction to the final reporting of the tables.
  • In addition, communicate with project manager and other team members, and assist in client Alnylam Pharmaceuticals Inc's inquiries on clinical trial related statistical analysis with developed SAS tools/techniques. Read More

Statistical Programmer

    

  • In this position, the candidate will work closely with project manager and other team member, assist in reviewing statistical analysis plan (SAP), study protocol, CRF, and analysis file specifications to make sure SAS codes are in compliance with the requirements of SAP and study protocol. Provide SAS programming support for the preparation of integrated reports and FDA submission. 
  • Develop and validate complex SAS programs to create tables, figures and listings (TFLs), generate and validate SDTM and ADaM datasets for multiple phase I-V studies, and  provide SAS programming specifications for CDISC SDTM and ADaM datasets, including proper validation, testing and documentation of CDISC STDM domain outputs, and integrated Summary of Safety and Efficacy (ISS/ISE) for FDA submission. 
  • Gather, maintain and analyze large scale of safety data that are collected during clinical trials, use solid SAS/STAT/MACRO/GRAPH/SQL techniques to interpret and report the data and generate Ad-hoc safety summary reports for review by research scientists and medical directors. Be responsible for checking whether the data are out of range of any safety guidelines provided by FDA or other agencies, and notify client in a timely matter on any abnormal test results. 
  • Review data collection and management methodology and assure acceptability and scientific integrity of data collection and analysis through appropriate application of probability principles and statistical methodology; create and modify standard SAS macros for validation, analysis and generation of clinical reports; provide high quality statistical analyses support for the clinical trial studies using statistical theory and SAS/STAT/MACRO/GRAPH/SQL techniques, and participate in preparing clinical study results for FDA submissions using SAS; write intense QC  
    documentation for every stage of reporting from extraction to the final reporting of the tables. 
  • In addition, work closely with project manager and other team member, and assist in client’s inquiries on clinical trial related statistical analysis with developed statistical techniques/tools. Read more

Business Management Analyst

  • As a professional Business Management Analyst, the candidate will join our business operations and management department, conduct business/projects studies and performance evaluations;  use statistical methods to collect, manage and interpret business data that assists and supports our management and marketing team with decision making, policy formulation and other managerial function on the company’s consulting projects and related services. 
  • Apply the principles of operation management and information systems across a wide range of disciplines, including operations, sales/marketing, human resources, administration and finance, to define problems, identify performance measures, and perform root cause analysis to identify alternatives and recommendations to improve business performance measures
  • Use accounting and financial methodologies to prepare and analyze financial report as related to financial analysis (i.e. forecast, profit-and-loss and expenses), provide financial-related strategy and budget variance, and to assist the company’s business operating more efficiently and effectively. 
  • Prepare documents and diagrams/charts to illustrate and describe company business operations, performance review, financial condition, and present findings and recommendations for implementation of procedures or organizational changes. 
  • Create reporting tools to simplify company’s financial and operational objectives, compile financial data and prepare projection reports, forecasting models to assist on the company’s project proposals and pricing decision by obtaining and verifying key financial data and expense reports. Research and analyze factors that contribute or reduce profitability, assess risks and benefits, including the internal risks like business model, cost efficiency, operational procedures, financial management, and external risks like market volatility, market competitors, macroeconomic.  
  • Perform risk assessment in relation to returns, including project budget planning process analysis and investment plan analysis, to identify the major negative consequences for the deficient management of operations.  Read more

SAS Programmer(s)

Talentech Consulting LLC (“Talentech”) is looking for professional SAS Programmer(s) to work on our clients’ clinical research projects.

General Responsibilities:

  • Collaborate with statisticians and other members of clinical study team to provide statistical programming support for Phase I-III clinical trials and post-marketing clinical trials activities; participate in the review of Statistical Analysis Plans (SAP) and clinical study protocol, Case Report File (CRF), and statistical methodology, statistical programming procedures, analysis file specifications, etc. 
  •  Develop and validate complex SAS programs to collect, manage, process and analyze clinical data, create tables, graphs and listings, and generate CDISC SDTM and ADaM datasets, including proper validation, testing and documentation for phase I-III studies. Provide programming specifications for CDISC SDTM and ADaM datasets. 
  • Create and modify standard SAS macros for validation, analysis and generation of clinical reports; provide high quality statistical analyses support for the clinical trial studies using solid statistical theory and SAS/STAT/MACRO/GRAPH /SQL techniques. 
  • Gather and interpret safety and efficacy data that are collected during clinical trials, review data collection and management methodology and assure acceptability and scientific integrity of data collection and analysis through appropriate application of statistical methodology and principles of probability.
  • Use statistical techniques to analyze the clinical trial data and generate Ad-hoc safety summary reports for review by research scientists and medical directors. Also you will be responsible for checking whether the data are out of range of any safety guidelines provided by FDA or other agencies, communicate with project manager and notify client in a timely manner on any abnormal testing results.  
  • Participate in preparing clinical study results for FDA submissions using SAS; writing intense QC documentation for every stage of reporting from extraction to the final reporting of the tables. In addition, communicate with project manager and assist in client’s inquiries on clinical trial related statistical analysis with developed SAS tools. Read more


Statistical Programmers

Talentech Consulting LLC (“Talentech”) is looking for professional Statistical Programmers to work on its clients’ clinical research projects. Read more

General Responsibilities:

  • Collaborate with statisticians and other members of clinical study team to provide statistical programming support for Phase I-III clinical trials and post-marketing clinical trials activities; participate in the review of Statistical Analysis Plans (SAP) and clinical study protocol, Case Report File (CRF), and statistical methodology, statistical programming procedures, analysis file specifications, etc. 
  • Develop and validate complex SAS programs to collect, manage, process and analyze clinical data, create tables, graphs and listings, and generate CDISC SDTM and ADaM datasets, including proper validation, testing and documentation for phase I-III studies. Provide programming specifications for CDISC SDTM and ADaM datasets. 
  • Create and modify standard SAS macros for validation, analysis and generation of clinical reports; provide high quality statistical analyses support for the clinical trial studies using solid statistical theory and SAS/STAT/MACRO/GRAPH /SQL techniques. 
  • Gather and interpret safety and efficacy data that are collected during clinical trials, review data collection and management methodology and assure acceptability and scientific integrity of data collection and analysis through appropriate application of statistical methodology and principles of probability.
  • Use statistical techniques to analyze the clinical trial data and generate Ad-hoc safety summary reports for review by research scientists and medical directors. Also you will be responsible for checking whether the data are out of range of any safety guidelines provided by FDA or other agencies, communicate with project manager and notify client in a timely manner on any abnormal testing results.  
  • Provide a variety of reporting events including: Clinical Study Report, Interim Analysis, Manuscripts and presentations, Submission to Regulatory Authorities (ISS/ISE, rapid response), Periodic Safety Report. 
  • Participate in preparing clinical study results for FDA submissions using SAS; writing intense QC documentation for every stage of reporting from extraction to the final reporting of the tables. In addition, communicate with project manager and assist in client’s inquiries on clinical trial related statistical analysis with developed SAS tools. Read more

Statistician

General Responsibilities:  As a Statistician,  general duties include but not limited to: 

  • Work closely with project manager and other team members, prepare and review statistical analysis plan (SAP), study protocol, CRF, and analysis file specifications
  •  Gather, maintain, analyze and interpret large scale of safety data that are collected either 
  • during pre-clinical studies conducted in bioresearch labs, or during clinical trials.
  • Use solid SAS/STAT/MACRO/GRAPH/SQL techniques to interpret and report the data and generate Ad-hoc safety summary reports for review by research scientists and medical directors. 
  • Perform statistical analysis using various statistical procedures and prepare final study report of statistical analyses, including information in the form of graphs, listings and tables, processing large amount of data for statistical modeling and graphic analysis using advanced SAS tools.  Evaluate the statistical methods and procedures used to obtain data to ensure validity, applicability, efficiency, and accuracy.
  • Develop and validate complex SAS programs, SAS macros to create tables, listings and graphs (TLGs), generate and validate SDTM and ADaM datasets;
  •  Provide SAS programming specifications for CDISC SDTM and ADaM datasets, including proper validation, testing and documentation of CDISC STDM domain outputs in accordance with SOPs, SOIs and guidance for multiple phase I- V clinical studies,  and integrated Summary of Safety and Efficacy (ISS/ISE) for FDA submission. 
  •  Manipulate, analyze and report CDISC data by SAS/STAT including PROC LIFETEST, PHREG, MEANS, SORT, FREQ, SUMMARY, TANSPOSE, COMPARE, NPAR1WAY, ARRAY. Provide statistical input for the preparation of final study reports and other required documents.
  •  In addition, work with project manager, assist clients in their inquiries on clinical trial related statistical analysis with developed SAS tools and techniques. Read more.

  

Requirements:   at least bachelor or higher degree in Statistics, Industrial Mathematics or close related fields. Master’s degree is highly preferred.  The candidate must be solid knowledge of statistics and statistical computing, strong skills in statistical methods, statistical analysis and SAS programming (using SAS/SQL/Macros/Graph and SAS report generation) for clinical study. 

Business Development & Management Analyst

  • Collect, manage, analyze and interpret business/financial data to support senior management and marketing team with decision making, policy formulation and budget planning on company's consulting projects and related services.


  • Prepare analysis reports to identify and interpret marketing/business trends. Analyze financial report to provide financial strategy and budget variance, and factors that contribute or reduce profitability, risks and benefits.


Rerequirement: Master' degree or equiv. in Business Administration, Management or related field, solid knowledge of business and marketing strategic planning, financial/budgeting management; strong skills in statistical & analytical tools (SPSS, STATA) in business area. 


*Send resume to Talentech Consulting LLC, 1100 Cornwall Road, Suite 160, Monmouth JCT, NJ 08852 Read More