K3-Innovations, Inc. · 8 hours ago
LEAD STATISTICAL PROGRAMMER
United States
Full-time
Remote
Senior Level, Lead/Staff
8+ years exp
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Hiring Manager
Ilene Brooks
Insider Connection @K3-Innovations, Inc.
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Responsibilities
Provides SAS programming support to all clinical studies.
Manages assigned programming CROs providing oversight and appropriate QC for programming deliverables.
Provide statistical programming support for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD).
Provides primary programming and QC support for any internally produced outputs.
Reviews and approves SAS programming instructions and CDISC/ADaM specifications.
Performs statistical analysis and simulations using SAS to support clinical trial design and data interpretation.
Reviews and provides input on eCRF design, external vendor data specifications, edit checks, and other Data Management related documents to ensure appropriate data collection for statistical programming.
Works closely with biostatisticians and data managers to identify data issues and generate queries that may impact statistical analysis and/or programming.
Works closely with biostatisticians and other functions (Pharmacovigilance, Clinical Development, etc.) to support data review for internal stakeholders.
Assists with ensuring consistency across programming methods in similar studies within a program.
Qualification
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Required
Bachelor’s Degree or Master’s degree or higher in statistics, biostatistics, or other closely related discipline with a minimum of 8 years of relevant experience in the pharmaceutical/biotechnology industry
Experience in applying clinical trial and statistical methodology to a variety of studies and indications across various phases of clinical development
Knowledge of pharmaceutical and regulatory requirements, procedures, and policies
Experience with BLA or NDA/sNDA submissions is required
Knowledge of GCP, ICH, 21 CFR part 11, and other Guidance documents and policies related to clinical trials operations requirements
In depth knowledge of CDISC and ADaM data set structures and requirements
Proficiency with SAS programming skills to including knowledge of SAS ODS graphical procedures such as PROC SGPLOT and the graphics template language (GTL)
Knowledge of all aspects of clinical drug development (Phase 1-4)
Experience working with a CRO partner
Excellent computer skills; strong verbal and written communication skills
Ability to work well in a team environment as a contributor
Open, engaging, and transparent work style
Ability to competently manage multiple competing priorities, switching priorities quickly as needs change
Must be comfortable working in a very fast-paced environment
Company
K3-Innovations, Inc.
At K3-Innovations, we are passionate about delivering exceptional clinical research services to the bio/pharmaceutical and medical device industries.
51-200 employees
H1B Sponsorship
K3-Innovations, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (5)
2021 (2)
2020 (2)
Funding
Current Stage
Growth StageCompany data provided by crunchbase
