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1+ months

Lead Statistical Programmer (REMOTE)

WIRB-Copernicus Group (WCG)
Work Remotely

General Information

Location: Bala Cynwyd, PA, Remote

Organization: ACI Clinical

Job Type: Full Time - Regular

Description and Requirements

JOB SUMMARY: Lead Statistical Programmer is responsible for leading and managing SAS programming activities for multiple clinical research projects and act as a technical resource for junior programmers.

VACCINATION REQUIREMENT:

To be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date.


EDUCATION REQUIREMENTS:

  • BS or BA required; degrees in computer science, math, Statistics or sciences preferred.

QUALIFICATIONS/EXPERIENCE:

  • At least seven (7) years industry experience.
  • Demonstrated proficiency in leading analysis & reporting programing activities for Phase I, II, III & IV Clinical trials.
  • Demonstrated skill in generating outputs to support downstream analysis requirements, e.g., ADaM specification and datasets creation, CSR/DMC/DSMB Tables, Figures and listings, Generation of Data Definition Tables for CDISC submissions
  • Experience in reading and transforming clinical trials data from EDCs, work with ODS, IMPORT, SAS-STAT procedures
  • Experience in developing data transfer documents and leading exchange of clinical trial data between vendors/CROs/sponsors
  • Demonstrated ability to coordinate project deliverables.
  • Outstanding attention to detail.
  • Strong written and verbal communication skills.
  • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
  • Attendance and punctuality are essential functions of the position.

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.

  • Serve as lead for all programming activities supporting DMC, DSM, 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
  • Perform quality control of standard and custom data listings, summary tables, and figures, as well as derived data sets and accompanying specifications
  • Review statistical analysis plans and assisting in the design of statistical data displays
  • Lead development and documentation of analysis datasets specification
  • Program standard and custom data listings, summary tables, and graphs as specified in statistical analysis plan, Adjudication and DMC charters
  • 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.
  • Work closely with programmers, internal cross-functional teams & client for project specifications, requirements documents, data transfers, status, issues, and requests.
  • Attend client and project status meetings as necessary.
  • Manage and create macro libraries, format catalogs, enhanced visual output displays, training presentation and documentation that can help drive programming efficiencies across studies & projects.
  • Assisting Director in ensuring programming adheres to ACI Standard Operating Procedures (SOPs).
  • Ensure programming is being done according to the SOP following sponsor specifications
  • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
  • Attendance and punctuality are essential functions of the position.

TRAVELREQUIREMENTS: 0% 5%

IND123

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Posted: 2021-08-26 Expires: 2021-09-26

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Lead Statistical Programmer (REMOTE)

WIRB-Copernicus Group (WCG)

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