Previous Job
Manager of Statistical Programming
Ref No.: 20-02913
Category: Experienced Professional
Location: Bala Cynwyd, Pennsylvania
Position Type:Direct Placement
Start Date: 03/04/2020
Genesis10 is seeking a Manager of Statistical Programming for a direct hire position with a our client in their Bala Cynwyd, PA location.

  • 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/Client).
  • 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).
  • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.

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

If you have the described qualifications and are interested in this exciting opportunity, apply today!

About Genesis10:
Genesis10 is a leading U.S. business and technology consulting firm with hundreds of clients needing proven talent and solutions to power their strategic initiatives. If you are a high performing business or IT professional with solid, referenced experience, we want to meet you. Genesis10 recruiters and delivery professionals are highly accomplished career advocates, who get to know you beyond your resume to position you with the opportunities that fit your skills, experience and aspirations. We have benefit options to fit your needs and a support staff that works with you from placement throughout your engagement project after project. To learn more about Genesis10 and to view all our available career opportunities, please visit us at "Genesis10 is an Equal Opportunity Employer, M/F/D/V