Principal Statistical Programmer /Analyst Consultant - Remote in USClinChoice Inc. • New York, New York, United States
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Principal Statistical Programmer /Analyst Consultant - Remote in US
ClinChoice Inc.
- New York, New York, United States
- New York, New York, United States
Über
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…
ClinChoice is searching for a
Principal Statistical Programmer Consultant
to join one of our clients.
The
Principal Statistical Programmer
will serve as a senior technical expert responsible for end-to-end programming deliverables, study leadership, and oversight of internal teams and external vendors. This role requires advanced expertise in
SAS , familiarity with
R , deep knowledge of
CDISC standards , and strong experience working on oncology studies and regulatory submissions.
Key Responsibilities
Technical Leadership:
Lead programming activities for oncology clinical trials across multiple studies, develop, validate, and maintain
SDTM
and
ADaM
datasets following CDISC guidelines, oversee production of
Tables, Listings, and Figures (TLFs) , provide SAS programming expertise for complex data derivations and analyses, review and ensure traceability, consistency, and quality of all programming deliverables.
Project & Study Management:
Act as programming lead for assigned studies, managing timelines and deliverables, work closely with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs, coordinate with CROs and external vendors, and support integrated analyses including
ISS/ISE .
Regulatory & Submission Support:
Prepare submission‑ready programming outputs and documentation (define.xml, annotated CRFs, reviewer guides), ensure compliance with FDA, EMA, PMDA requirements, and contribute to regulatory queries and data requests.
Required Qualifications
Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
8–12+ years of statistical programming experience in pharma/biotech or CRO.
Expert‑level proficiency in
SAS .
Strong understanding of
CDISC SDTM and ADaM
standards.
Significant experience supporting oncology clinical trials (hematologic or solid tumors).
Experience supporting regulatory submissions and preparing submission‑ready outputs.
Excellent communication skills and ability to collaborate cross‑functionally.
The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you meet our requirements, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Equal Employment Opportunity ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds, and we celebrate this strength.
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Sprachkenntnisse
- English
Hinweis für Nutzer
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