General Information

Location: Bala Cynwyd, PA

Organization: ACI Clinical

Job Type: Full Time - Regular

Description and Requirements

SUMMARY OF POSITION: As statistical programming lead, this role is responsible for development and validation of all data displays and statistical summaries presented to expert committees. Working closely with statistician, data mangers and clinical Specialists, this role is also responsible for overseeing dataset specification development, generation of SEND, SDTM, and Analysis/ADaM datasets ensuring development and validation of outputs are in compliance with standard operating procedures.

EDUCATION REQUIREMENTS:
BS or BA requires, Master’s Degree preferred

QUALIFICATIONS/EXPERIENCE:
-At least five (5) years industry experience
-Demonstrate technical expertise in SAS programming
-Outstanding organizational and leadership skills
-Excellent 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.
-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.
-Perform quality control of standard and custom data listings, summary tables, and figures, as well as derived data sets and accompanying specifications
Serve as lead for all programming activities supporting adjudication and safety committees.
-Accountable for all programming activities supporting Patient Profiles, Data transfers, Analysis outputs, Standard and Custom data listings to support adjudication and Data Monitoring committee.
-Reviewing statistical analysis plans and assisting in the design of statistical data displays
-Lead development and documentation of analysis datasets specification
-Lead data pooling and analysis of both safety and efficacy (ISS/ISE).
-Perform quality control of SDTM, SEND, ADaM datasets based on CDISC SDTM/ADaM/SEND dataset specifications.
-Author, review and finalize study data reviewers guide for SDTM, ADaM and SEND submission studies.
-Responsible for high quality delivery of SDTM, ADaM, SEND based submission artifacts including Annotated CRFs, Specifications, Datasets, Reviewers Guide and define.xml
-Responsible for review and resolution of data integrity/compliance issues identified from Pinnacle 21 and other validation/quality tools.
-Assisting in the coordination of programming tasks for current projects in ACI.
-Attending client meetings as necessary.
-Assisting in the cultivation of new business development opportunities, including preparing and presenting company capabilities for perspective clients, developing Request For Information/Proposals (RFI/RFP), creating and approving study budgets, and assisting in resource allocation.
-Assisting Director in ensuring programming adheres to ACI Standard Operating Procedures (SOPs).
-Overseeing and assisting in the validation and documentation of programming software
-Implementing and following the latest versions of CDISC, FDA guidelines, Good Clinical Practice, and other industry standards.