Statistical Analyst

Alpha Stats Inc offers an environment for personal growth and creativity. Employeesare encouraged to acquire new skills and are sponsored for professional seminarsand conferences. Alpha Stats is currently seeking Data Managers, Biostatisticiansand SAS Programmers on a full-time and contract basis. Statistical Analyst having below described qualifications and experiences is needed to work at our facility in Piscataway, New Jersey 08854

JOB REQUIREMENTS

Develop datasets from raw clinical trial data based upon current industry standards. Develop and validate Tables, Listings and Graphs (TLGs) for submission to regulatory authorities worldwide. Review Case Report Forms (CRF), protocols, Statistical Analysis Plans (SAP). Develop and validate SDTM and ADaM datasets, Define.PDF and Define.XML complying with CDISC standards and FDA guidelines. Utilize SAS MACROS and SAS SQL to validate TLGs. Write specifications for SDTM, ADaM datasets and Tables, Listings and Graphs (TLGs). Co-ordinate project activities with Data Management, Clinical Study Biostatistics, Clinicians and Regulatory Teams; Create reports for review by the management.

EDUCATION AND EXPERIENCE REQUIREMENTS

M.S. in Biostatistics, Bioinformatics or Biotechnology. At least 2 year of experience in the job offered

SKILL AND OTHER REQUIREMENTS

Must have knowledge of SAS Software, Survival Analysis and Clinical Data Analysis. We are looking for a highly-motivated Biostatistician on W2 or 1099 basis.This position provides statistical support for all phases of clinical development.Specific responsibilities include writing statistical analysis plans and statisticalsections of protocols, and developing SAS programs for inferential analysis.

JOB REQUIREMENTS

Write Statistical Analysis Plans and develop table and listing shells Provide sample size calculations Quality control of randomization schedules Provide input into development of case report forms (CRFs) Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests Perform quality control for SAS programs and other study documents Provide statistical analysis and reports to Data Monitoring Committees (DMCs) Review outputs across programs to ensure consistency Prepare statistical sections of clinical study reports Complies with company SOPs and regulatory guidance

EDUCATION AND EXPERIENCE REQUIREMENTS

PhD. in statistics or biostatistics with at least 3 years or MS in statistics or biostatistics with at least 5 years experience in pharmaceutical industry Knowledge of industry standards, such as the ICH guidelines, 21 CFR Part 11, CDISC data structures, and FDA guidelines

SKILL AND OTHER REQUIREMENTS

Strong in SAS programming Excellent organizational skills, time management, ability to coordinate workload and meet established deadlines, and a good team player Excellent communication and interpersonal skills to effectively interface with others We are looking for a candidate with BS-Medical Statistics or Pharmaceutical Statistics or any pharmacy related fields with at least 2 years experience in the job offered or anyfield related to Statistical Analyst, to develop project-specific data management plans.

JOB REQUIREMENTS

Clinical data coding, reporting, or transfer, database locks, and work flow processes Develop SAS programs to generate summary tables, data listings and graphs to accelerate FDA approval of new drugs Create edit checks and validate analysis datasets, SAS programs, tables, listings and Graphs Define analysis dataset specification and ensure implementation according to standard operating procedures Perform data analyses using statistical techniques including Analysis of Covariance, Logistic Regression, application of p-values and confidence intervals Participate in the review of Case Report Forms (design phase), Statistical Analysis Plans, QC Specifications and Database Structures

EDUCATION AND EXPERIENCE REQUIREMENTS

BS-Medical Statistics or Pharmaceutical Statistics or any pharmacy related fields with at least 2 years experience in the job offered or any field related to Statistical Analyst

SKILL AND OTHER REQUIREMENTS

Must have prior experience of SAS Base and Statistical Procedures; SAS Programming and Phase I-IV clinical trials Must have knowledge of SAS software, including SAS/STAT, SAS/Macro, SAS/GRAPH and SAS/SQL #J-18808-Ljbffr Alpha Stats Inc