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AD - Senior Statistical Programmer

Hays

West Virginia • Today

Full-time

Senior Statistical Programmer

Atlas Search

West Virginia • Today

Full-time

Senior Directory Services Engineer (Active Directory Expert) Remote

Dexter Technologies

Remote • 8d ago

Easy Apply

Contract

Depends on Experience

Senior Directory Services Engineer (Active Directory Expert)

Dexter Technologies

Remote • 8d ago

Easy Apply

Full-time

Depends on Experience

Sr. System Engineer - Active Directory Infrastructure

CPI International

Remote or Plano, Texas • Today

Full-time

Senior SAS programmer (RWE)

Katalyst Healthcares and Lifesciences

Remote or New York, New York • 12d ago

Full-time

Active Directory Administrator

Spruce Technology Inc.

Remote • Yesterday

Easy Apply

Contract, Third Party

Depends on Experience

Senior IAM Engineer

Centene Corporation

Remote or Missouri • Today

Full-time

USD 87,000.00 - 161,300.00 per year

Senior Data Scientist

Vanta

Remote • Today

Full-time

USD 172,000.00 - 202,000.00 per year

Senior Data Scientist

Amplify

Remote • Today

Full-time

USD 138,000.00 - 158,000.00 per year

Senior Data Scientist

Doximity

Remote or San Francisco, California • Today

Full-time

Compensation information provided in the description

Sr. Principal Software Development Analyst - TS Analyst Lead (26-336)

Northrop Grumman

Remote or Huntsville, Alabama • Today

Full-time

USD 135,800.00 - 203,600.00 per year

Senior Data Scientist

Angi

Remote • Today

Full-time

USD 185,000.00 - 240,000.00 per year

Senior Data Scientist, Ads Marketplace

Etsy, Inc

Remote or New York, New York • Today

Full-time

Senior Analytics Program Manager (Remote: Must Live in OR, WA, ID, UT, or ND)

Motus Recruiting & Staffing

Remote or Hybrid in Portland, Oregon • 18d ago

Contract

70 - 75

Sr. Data Scientist

Hims and Hers Health, Inc.

Remote • Today

Full-time

USD 150,000.00 - 180,000.00 per year

Staff Data Engineer- Ohio or EST Time Zone

Netwrix Corporation

Remote • 4d ago

Full-time

IT Platform Administrator (ARL)

Penn State

Remote or State College, Pennsylvania • Today

Full-time

USD 80,100.00 - 132,204.00 per year

Senior Data Scientist

OneStudyTeam

Remote • Today

Full-time

USD 140,000.00 - 190,000.00 per year

Senior Data Science Engineer/Specialist

Concurrent Technologies Corporation

Remote or Johnstown, Pennsylvania • Today

Full-time

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 3 hours ago

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Sr Manager, Programming Infrastructure & Analytics Enablement

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At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great P

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Senior RAVE Clinical Database Programmer

Remote or New Jersey

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12d ago

Job Description: The Senior RAVE Clinical Database Programmer participates in the design, development, validation, and maintenance of clinical study databases. This individual applies advanced knowledge of CRF design, database configuration, edit check programming, custom programming, reporting, system integrations, and CDMS functionality while partnering closely with Clinical Data Management and cross-functional study teams to support successful clinical trial execution. Key Responsibilities:

Full-time

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

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.

\\n
Study Execution
\\n

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.

\\n
Regulatory Support
\\n

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.

\\n
Vendor Oversight
\\n

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.

\\n
Cross-Functional Collaboration
\\n

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.

\\n

\\n
Qualifications Required
\\n

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.

\\n
Preferred
\\n

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.

\\n

Dice Id: orcfeed
Position Id: 24495_29249_649b6a312c9499cb
Posted 3 hours ago

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Senior Statistical Programmer

West Virginia

•

Today

Full-time

Senior R/Python Application Developer

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