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1+ months

Manager, Statistical Programming

WIRB-Copernicus Group (WCG)
Bala Cynwyd, PA 19004

General Information

Location: Bala Cynwyd, PA

Organization: ACI Clinical

Job Type: Full Time - Regular

Description and Requirements

EDUCATION REQUIREMENTS

  • BS/BA required or equivalent experience; degrees in computer science, math or sciences preferred. 

QUALIFICATIONS/EXPERIENCE: 

  • At  least  8  years  of  experience  w/SAS  in  the  pharmaceutical  industry  supporting  analysis  and reporting for Phase I, Phase II, Phase III, Phase IV clinical trials data. 

  • Experience  in  mapping  clinical  study  data  to  standard/submission/repository  data  models  and programming experience converting raw data to the data models

  • Experience  in  developing  data  transfer  documents  and  leading  exchange  of  clinical  trial  data between vendors/CROs/sponsors

  • Demonstrated technical expertise in SAS programming.

  • Outstanding attention to detail. 

  • Strong written and verbal communication skills. 

ESSENTIAL DUTIES/RESPONSIBILITIES: 


To perform this job successfully, an individual must be able to perform  each  essential  duty  and  responsibility  satisfactorily. The  requirements  listed  below  are representative of the knowledge, skills, and/or ability required

  • Lead  and  perform  data  manipulation,  analysis  and  reporting  of  clinical  trials  data  to  support Adjudication, Data Monitoring and Safety committees. 

  • Develop, review and maintain analysis dataset specifications and programming deliverables to high standard of quality and accuracy.

  • Responsible  for  high  quality  delivery  of  SDTM,  ADaM  and  SEND  based  submission  artifacts including Annotated CRFs, Specifications, Datasets, Reviewers Guide and define.xml. 

  • Lead data pooling and analysis of both safety and efficacy (ISS/ISE). 

  • Serve as lead for all programming activities supporting adjudication and safety committees. 

  • Responsible for programming and validation of Patient Profiles, Data transfers, Analysis outputs, Standard and Custom data listings to support adjudication and Data Monitoring committee. 

  • Program standard and custom data listings, summary tables, and graphs as specified in Charter, statistical analysis plan and requirements documents. 

  • Work  closely  with  programmers  and  internal  cross-functional  teams  and  client  for  project specifications, data transfers, status, issues, and requests. 

  • Develop and review SDTM, ADaM, SEND data set specification as per the CDISC SDTM, ADaM, SEND guidelines and ensure they meet downstream TFL/Reporting requirements. 

  • Review and approve Annotated CRFs per submission data standard guidelines and / study and sponsor specific metadata guidelines. 

  • Author, review and finalize study data reviewers guide for SDTM, ADaM and SEND submission studies. 

  • Perform quality control of  SDTM, SEND, ADaM data sets based on CDISC SDTM/ADaM/SEND dataset specifications. 

  • Responsible for review and resolution of data integrity/compliance issues identified from Pinnacle 21 and other validation/quality tools. 

  • Perform quality assurance procedures on work performed by other programmers. 

  • Provide input into case report form design, database structure design, and edit check development. 

  • Review statistical analysis plans and assist in the design of statistical data display. 

  • Providing  input  into  case  report  form  design,  database  structure  design,  and  edit  check development. 

  • Assist in the coordination of programming tasks for current projects in ACI. 

  • Assist the biostatistics department with developing tools and techniques for improving process. 

  • Implement and follow the latest versions of CDISC, FDA guidelines, Good Clinical Practice, and other industry standards. 

  • Maintaining and improving upon structure for programming group, including but not limited to the creations  of  macros  libraries,  format  catalogs,  enhanced  visual  output  displays,  training presentation and documentation, and other programming methodologies. 

  • Assist Director in ensuring programming adheres to ACI Standard Operating Procedures (SOPs). 

 

SUPERVISORY RESPONSIBILITIES:  none 

TRAVEL REQUIREMENTS:  none 


Categories

Posted: 2020-04-14 Expires: 2020-06-07

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Manager, Statistical Programming

WIRB-Copernicus Group (WCG)
Bala Cynwyd, PA 19004

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