Lead Statistical Programmer - Global Studies (Remote) Job at RemoteWorker US, Fairfield, CT

dlFnRWl0QzVLemxldk9yWEpkNjI5ZVQwdVE9PQ==
  • RemoteWorker US
  • Fairfield, CT

Job Description

Contact: Neisha Camacho/Terra Parsons - teamnt@penfieldsearch.com
No 3rd party candidates

We are seeking a highly experienced Statistical Programmer to lead programming activities across global clinical studies. This role operates beyond executional programming, with responsibility for oversight of CRO deliverables, validation of outputs, and end-to-end accountability for statistical programming packages.

Key Responsibilities

  • Lead statistical programming activities across global studies (EU and China exposure preferred)

  • Serve as primary programming lead in collaboration with Biostatistics

  • Develop, review, and validate SDTM and ADaM datasets in accordance with CDISC standards

  • Review specifications and proactively challenge inconsistencies in protocols, SAPs, and dataset definitions

  • Validate program outputs and ensure accuracy, quality, and regulatory compliance

  • Provide oversight and guidance to CRO partners, consolidating and communicating feedback effectively

  • Manage timelines, delivery packages, and milestone commitments

  • Contribute to continuous improvement of programming processes and standards

Core Requirements

  • Strong expertise in CDISC standards, including ADaM and SDTM

  • Demonstrated experience reviewing specs and ensuring high-quality, submission-ready deliverables
  • Working experience in LSAF environment
  • Experience validating CRO programming deliverables
  • Ability to operate with increased performance accountability and ownership
  • Strong CRO-facing communication and collaboration skills
  • Proven ability to manage multiple global studies simultaneously

Qualifications

  • Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, or related field

  • 5+ years of SAS programming experience within pharmaceutical/biotech
  • Strong understanding of statistical methods used in clinical trial analysis
  • Knowledge of Good Programming Practices and GCP

Preferred

  • Experience with R programming

Additional Requirements

  • Hands-on experience with LSAF - Life Sciences Analytical Framework

  • Practical experience with multiple imputation (MI), particularly under Missing at Random (MAR) assumptions
  • Familiarity with the estimands framework (ICH E9 R1) and managing intercurrent events (ICEs) within ADaM domains using various strategies

Job Tags

Contract work, Work experience placement, Remote work

Similar Jobs

Gpac

Commercial Roofing Estimator Job at Gpac

We are seeking an experienced assertive, dynamic, ambitious Commercial Roofing Estimator who can continue our long tradition of successful roofing solutions by providing quality workmanship. We have had many employees working for 20 years and longer both in the office and... 

Massachusetts Maritime Academy

Part-Time Data Analyst Job at Massachusetts Maritime Academy

 ...Responsibilities The Institutional Research Data Analyst contributes to institutional research efforts...  ..., accreditation, and program review. This part-time position is up to 30 hours, 3-4 days/week. Up to two remote days/week possible, depending on schedule, after... 

Gordini USA Inc

Credit Manager Job at Gordini USA Inc

 ...credit limits that enable growth while managing risk Monitor accounts receivable and aging trends; take a proactive, solutions-driven...  ...support Gordinis continued growth ~ Bachelors degree in Finance, Accounting, Business, or related field (preferred)~5+ years... 

DePaul

SRO Administrative Assistant Job at DePaul

 ...updating of logs, listings, staff rosters, etc. # Responsible for updating records of staff trainings and requirements as needed (i.e., PPD, First Aid, Universal Precautions, Exposure Control, etc.). # Maintains all personnel files, assuring they are complete, organized,... 

Southcoast Health System

Manager-Radiology Imaging Services Job at Southcoast Health System

 ...for yourself why Southcoast Health has been voted Best Place to Work for 7 years in a row! We are searching for a talented Manager-Radiology Imaging Services A career at Southcoast Health offers you: ~ A culture of well-being that embraces respects and...