AD - Senior Statistical Programmer

United, WV, US • Posted 2 hours ago • Updated 2 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

IT Management
Clinical Data Management
Medical Writing
SAP
Database
Regulatory Compliance
Quality Control
NDA
Regulatory Affairs
Partnership
Collaboration
Data Management
Mentorship
Process Improvement
Statistics
Mathematics
Computer Science
Biostatistics
Life Sciences
Pharmaceutics
Biotechnology
SAS
CDISC
SDTM
Clinical Trials
XML
Documentation
Management
Communication
Leadership
People Management

Summary

Job Description

About the Company
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Our client is a clinical-stage biotechnology company focused on developing innovative immuno-oncology therapies designed to transform outcomes for patients with cancer. Backed by strong scientific leadership and investor support, the organization offers the agility and visibility of a small biotech environment while advancing a promising clinical pipeline.
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This is an opportunity to join a highly collaborative team where Statistical Programming plays a strategic role in clinical development and regulatory submissions.
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Position Summary
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The Associate Director of Statistical Programming will provide technical leadership and hands-on programming support across clinical development programs. This individual will collaborate closely with Biostatistics, Clinical Data Management, Clinical Operations, Medical Writing, and external CRO partners to ensure timely delivery of high-quality statistical programming outputs.
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The ideal candidate will have extensive experience supporting oncology or immuno-oncology clinical trials and possess strong expertise in CDISC standards, regulatory submissions, and SAS programming. Experience overseeing CROs while remaining hands-on with programming deliverables is highly desirable.
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Key Responsibilities
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Statistical Programming Leadership
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Lead statistical programming activities across Phase I, II, and III clinical studies.
Develop and review SDTM, ADaM, and TLF deliverables to support clinical development and regulatory submissions.
Provide strategic programming expertise during protocol development, SAP development, study conduct, and database lock activities.
Ensure compliance with company SOPs, ICH guidelines, and regulatory requirements.

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Study Execution
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Generate and validate Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions.
Create analysis datasets and support efficacy, safety, biomarker, and pharmacokinetic analyses.
Perform independent quality control reviews of programming outputs.
Support interim analyses, data monitoring committee meetings, and ad hoc analyses.

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Regulatory Support
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Contribute to NDA, BLA, IND, and other global regulatory submissions.
Prepare submission-ready datasets and define.xml documentation.
Collaborate with Regulatory Affairs and Biostatistics to address health authority requests.

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Vendor Oversight
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Serve as the primary Statistical Programming representative for external CRO partnerships.
Review programming specifications, timelines, and deliverables provided by vendors.
Ensure consistency, quality, and adherence to CDISC standards across programs.

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Cross-Functional Collaboration
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Partner closely with Biostatistics, Clinical Development, Clinical Operations, Medical Affairs, and Data Management teams.
Provide programming input on study design, data standards, and analysis strategies.
Mentor junior programmers and contribute to process improvements and department growth.

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Qualifications Required
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Bachelor\'s degree in Statistics, Mathematics, Computer Science, Biostatistics, Life Sciences, or related discipline.
8+ years of Statistical Programming experience within the pharmaceutical, biotechnology, or CRO industry.
Advanced proficiency in SAS programming.
Strong experience with:
CDISC SDTM and ADaM standards
TLF generation
Oncology clinical trials
Regulatory submissions (FDA and global agencies)
Define.xml and submission documentation
Experience overseeing CRO programming activities.
Strong verbal and written communication skills.

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Preferred
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Master\'s degree in a relevant scientific discipline.
Immuno-oncology experience.
Experience supporting early-phase oncology studies.
Knowledge of R programming.
Experience with electronic submission processes and Pinnacle 21.
Prior leadership or people management experience.

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Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: orcfeed
Position Id: 24495_29249_649b6a312c9499cb
Posted 2 hours ago

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