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CAREER OPPORTUNITIES

 

Alpha Stats Inc offers an environment for personal growth and creativity. Employees are encouraged to acquire new skills and are sponsored for professional seminars and conferences. Alpha Stats is currently seeking Data Managers, Biostatisticians and SAS Programmers on a full-time and contract basis.

 


Senior Statistical Analyst

 

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Sr. Statistical Analyst wanted for Alpha Stats Inc. in South Plainfield, New York, with M.S. in Biostatistics, Bioinformatics or related fields, & At least 1 year experience in the job offered or any occupations related to Statistical Analysis, to perform the following:

 

RESPONSIBILITIES

  • Perform analyses using statistical techniques including Analysis of Covariance, Logistic Regression, Survival Analysis, Fisher's Exact Test and Chi-Square Test.
  • Develop SAS programs to generate summary tables, data listings and graphs, using BASE SAS, SAS/SQL, SAS/Macro, and SAS/Graph, to accelerate FDA approval.
  • Develop Integrated Summary of Safety and Efficacy datasets and reports required for regulatory authority submissions.
  • Review protocol, CRFs, and statistical analysis plans.
  • Create Master/Analysis datasets.
  • Use SAS MACRO, SAS SQL to validate tables, listings and graphs.
  • Perform edit checks for quality assurance of clinical databases.
  • Perform analysis of clinical outcome research data collected from clinics and hospitals for safety and efficacy evaluation of pharmaceutical formulations.
  • Co-ordinate project activities with clinical study biostatisticians, clinicians, Data management and regulatory teams.

Specific Skills and other Requirements

  • Prior experience must include: SAS programming and Phase I-IV clinical trials in pharmaceutical industry, and IND/NDAs application.
  • Must have knowledge of: SAS software, including SAS/STAT, SAS/Macro, SAS/GRAPH and SAS/SQL; and Analysis of Covariance, Linear Regression, Logistic Regression, Fisher's Exact Test, Chi-Square test, and Survival Analysis.

POSITION TITLE

  • Senior Statistical Analyst

DURATION

  • Regular
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Biostatistician

 

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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 statistical sections of protocols, and developing SAS programs for inferential analysis.

 

RESPONSIBILITIES

  • 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

QUALIFICATION, SKILLS & ABILITIES

  • 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
  • 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

POSITION TITLE

  • Senior Biostatistician or Contractor

DURATION

  • 12+ months for contractor
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Senior Clinical Data Analyst

 

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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 any field related to Statistical Analyst, to develop project-specific data management plans.

 

RESPONSIBILITIES

  • 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

QUALIFICATION, SKILLS & ABILITIES

  • 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
  • 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

POSITION TITLE

  • Senior Clinical Data Analyst

DURATION

  • Full time, Long term
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