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Sr. Statistical Programmer – Level 1

Clymb Clinical
Burlington, MA

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Job Details

Full-time

Qualifications

FDA submissions
Data compliance
XML
SAS
SAS language
CDISC standards
Quality control operations
Regulatory compliance analysis
Cross-functional communication
Metadata creation

Full Job Description

Burlington, MA

Job ID: CC-2401

Our group is growing rapidly, and we are currently seeking a full-time, Sr. Statistical Programmer – Level 1 to join our team. This is a critical role contributing both to our Services and Product Development teams. This position requires this individual to work onsite at our new Burlington, MA office. Applicants must reside within a 50-mile radius of Burlington, MA site.

This position is direct hire, no third parties please.

Primary job role

The Sr. Statistical Programmer - Level 1 will develop and validate technical programming specifications and programs, and generate SDTM and ADaM datasets, tables, figures, and listings. The incumbent should be able to work independently implementing and executing the programming and project standard to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis.

Responsibilities

o Conduct a comprehensive review of study documents, including Protocol, CRF, and SAP.
o Create and assess statistical programs in SAS and/or R to produce CDISC-compliant SDTM and ADaM datasets.
o Execution of validation and quality control procedures for programs, datasets, and statistical reports, ensuring alignment with study requirements.
o Development and review CDISC SDTM and ADaM mapping specifications.
o Produce and review Tables, Figures, and Listings (TFLs) in accordance with the statistical analysis plan.
o Review datasets for any pending compliance issues and meticulously document identified issues.
o Generation and review of submission documents like define.xml, SDTM annotated CRF, and reviewers guide.
o Generation of utility macros and efficient code writing to streamline programming processes.
o Communicate effectively within project teams to ensure the timely and budget-compliant completion of assigned tasks.
o Adherence to Clymb and/or client’s Policies and Procedures.

Requirements:

o Master’s degree or equivalent, along with relevant formal academic/vocational qualifications and a minimum of 3 years of SAS programming experience. Alternatively, a Bachelor’s degree with at least 5 years of SAS programming experience.
o A minimum of 2 years of hands-on CDISC implementation experience. Any experience with R programming will be considered a significant plus.
o Proficiency in SAS Programming.
o Previous involvement as a production or QC programmer at both product and study levels.
o Strong organizational, interpersonal, leadership, and communication skills.
o Ability to autonomously manage multiple tasks and projects.
o In-depth understanding of FDA regulatory guidance around Study Data and Submission, including familiarity with the Study Data Technical Conformance Guide, FDA Data Submission Standards Catalog, and associated requirements.
o A minimum requirement of a strong understanding of CDISC Metadata Submission Guidelines (MSG), Define standards, CDASH, SDTM, ADaM, and controlled terminology standards.

Position

Senior level 1 (Contract to Perm)

Education

Master’s degree required, Masters in statistics, computer science, mathematics, engineering, or life science preferred.

Experience

3+ Years

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Sr. Statistical Programmer – Level 1

Biostatistician I - Rehabilitation and Human Performance