Jobs in the United States

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Chemist I - GCMS (M-F, 1p-10p) Eurofins Environment Testing Southwest, Calscience, Tustin, CA
Eurofins
Tustin, CA
- $18 to $22 USD / hour
…logistics and continuous investment in people, technology, and…
Added 3 mins ago
Sr. Design Project Manager - Large Projects
Arcadis
Miami · Avon Park · Dillwyn · Washington · Winters · Phoenix
Experience with design-build, EPC/EPCM, mission-critical, advanced technology, industrial, infrastructure, or other complex projects preferred.
Added 5 mins ago
Senior Cost Manager / Quantity Surveyor - Data Center Construction
Turner & Townsend
Richmond, VA
Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering outcomes that improve people’s lives. Working in partnership…
Added 6 mins ago
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Intermediate Data Engineer
Denver, CO · Cedar Rapids, IA
- $77,000 to $95,000 USD / year
Build and support the operation of Cloud and On-Premises enterprise data infrastructure and tools.
Added 7 mins ago
Program Director, Roads and Highways, Houston
Parsons Transportation Group
TX
…construction management, and software solutions to a wide range of infrastructure clients, mainly in North America. We’re an industry leader in successfully delivering complex, challenging,…
Added 7 mins ago
Telemetry Engineer
Parsons Government Services Inc.
AL
…solutions in the areas of defense, security, intelligence, infrastructure, and environmental. We promote a culture of excellence and close-knit teams that take pride in delivering,…
Added 8 mins ago
Senior Director, AI Platform Engineering Management
ServiceNow
Santa Clara, CA
…agent, and dataset across the enterprise. We’re building the infrastructure enterprises will depend on as agentic AI moves from experimentation into…
Added 9 mins ago
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Oracle Health Senior Organizational Change Consultant
Oracle
Santa Fe, NM
- $71,200 to $166,100 USD / year
Only Oracle brings together the data, infrastructure, applications, and expertise to power everything from industry innovations to life-saving care. And with AI embedded across our products…
Added 9 mins ago
Platform Engineer
ASM Research, An Accenture Federal Services Company
Santa Fe, NM
The Platform Engineer (Ops Technology Lead) is responsible for designing, implementing, and maintaining IT infrastructure platforms within the CASTLE-NET program, ensuring reliability,…
Added 9 mins ago
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Principal Consultant - FirstNet
Oracle
Santa Fe, NM
- $71,200 to $166,100 USD / year
Added 9 mins ago
Network Security Engineer Master
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Santa Fe, NM
…troubleshooting, and continuous improvement of enterprise network-security infrastructure. This role is responsible for Palo Alto Networks next-generation firewalls, Panorama, High…
Added 9 mins ago
Senior IT Project Manager (NSGS)
GovCIO
Santa Fe, NM
GovCIO is seeking a Senior IT Project Manager to support mission-critical infrastructure modernization programs for the U.S. Coast Guard (USCG). This position will serve as a key technical…
Added 9 mins ago
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Customer Service Rep – Healthcare (Seasonal, Remote)
Concentrix
Santa Fe, NM
- $15 to $17 USD / hour
One of our company’s Culture Beliefs says, “We champion our people.” That’s why we invest in our game-changers, our infrastructure, and our capabilities to ensure long-term success for both…
Added 9 mins ago
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Senior Product Marketing Manager, Field
Akamai Technologies, Inc.
Santa Fe, NM
- $132,100 to $237,900 USD / year
Have practical and technical knowledge of cloud computing, infrastructure, or developer platforms, paired with strong product marketing, market, and business acumen
Added 9 mins ago
Senior Staff SRE, Site Experience
Reddit
Remote, United States
The Site Experience SRE team sits at the intersection of infrastructure, product engineering, and user experience - ensuring that every interaction across web, mobile, APIs, feeds, media…
Added 10 mins ago
Planner/Scheduler
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Chandler, AZ
…jobs, grown economies, improved the resiliency of the world's infrastructure, increased access to energy, resources, and vital services, and made the world a safer, cleaner…
Added 10 mins ago
CO
Information Technology Security Administrator
City of Culver City
Culver City, CA
- $53 to $64.7 USD / hour
…technical services include desktop support, system analysis, infrastructure security/maintenance, and training. The IT Public Safety Division provides technology support services to the…
Added 10 mins ago
Manager, Field Services (4 Days Onsite- Brentwood, TN
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BRENTWOOD, TN
Coordinates implementation of field solutions, including network infrastructure, wireless systems, telecommunications, endpoint devices, structured cabling, physical security technologies,…
Added 14 mins ago
Supply Chain & In-Plant Logistics Planning Manager (New Plant Readiness)
Daimler Truck North America LLC
Portland, OR · Detroit, MI · Fort Mill, SC
Define material-flow routes, inventory strategies, space, staffing, equipment, infrastructure, and service requirements.
Added 14 mins ago
Custom Truck Services & Outbound Logistics Planning Manager (New Plant Readiness)
Daimler Truck North America LLC
Portland, OR · Detroit, MI · Fort Mill, SC
Confirm infrastructure for finished vehicle operations meets requirements for optimized processes, layout, tooling, handoff, and load dispatch staging.
Added 15 mins ago
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EverHealth - Forward Deployed Engineer (Remote, US)
Evercommerce
Remote, United States
- $140,000 to $170,000 USD / year
Added 15 mins ago
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EverHealth - Lead Forward Deployed Engineer (Remote, US)
Evercommerce
Remote, United States
- $170,000 to $200,000 USD / year
Added 15 mins ago
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EverHealth - Software Engineer
Evercommerce
Remote, United States
- $130,000 to $160,000 USD / year
Added 16 mins ago
Associate Director, Regulatory Affairs
Summit Therapeutics
Remote, United States
…processes and timelines, regulatory tracking tools, archives, and infrastructure, as…
Added 22 mins ago
Executive Recruiter
Everpure
Santa Clara, CA
Access to senior talent in highly contested markets across enterprise infrastructure, data platforms, AI and cloud, in every region where Everpure operates

X4 Pharmaceuticals INC

Director, Statistical Programming

Boston, MA, United States

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Job details

Posting language: English

Original job description

Do you have the passion and commitment to join a group whose mission is to develop treatments that have a clear, profound impact on patients with rare diseases? Does it excite you to be a part of a patient-focused company developing potential new treatments that could dramatically improve the lives of patients with limited to no current treatment options? If yes, we encourage you to share with us your aspirations and career goals. X4 is focused on restoring healthy immune system function by developing novel therapeutics to treat chronic neutropenic disorders, including WHIM syndrome, a rare primary immunodeﬁciency. We are advancing a novel, late-stage clinical candidate, mavorixafor, that we believe has the potential to become a new standard of care for patients with these disorders. We know that developing innovative, new medicines is challenging, and we invite new colleagues who share our values and commitment to join us in achieving our mission.

Accountabilities and Responsibilities:

Reporting to the Senior Director, Biostatistics, you will be responsible for overseeing statistical programming activities across X4’s portfolio, managing CROs, providing hands-on programming support and technical guidance on clinical trials and regulatory submissions, building and maintaining programming infrastructure, and ensuring compliance with SOPs to produce quality and timely deliverables. He/she must possess extensive experience and proven skills in the use of SAS and complete knowledge and understanding of the statistical programming processes, procedures, and roles. He/she will use knowledge of CDISC SDTM and ADaM standards to statistical analysis, including generating analysis data, tables, and figures and create all files necessary to support an electronic submission in the eCTD format. Additionally, this individual will participate in departmental and cross functional technology development and process improvement initiatives.

Effectively design and develop SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS.
Develop and deliver CDISC and regulatory compliant SDTM, and ADaM standard datasets.
Develop and execute statistical analysis and reporting deliverables (tables, figures and listings (TFLs)) in a timely and high-quality manner.
Provide input in the design and development of case report forms and clinical study databases.
Collaborate with cross-functional teams to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, and product launch.
Drive and oversee Statistical Programming activities internally and externally (CRO), and act as project manager for statistical programming deliverables.
Assess and perform quality control checks/validation of SAS code and output produced by vendors or other Statistical Programmers for SDTM datasets, ADaM datasets, and TFLs.
Author and review SDTM and ADaM datasets specifications for datasets programming.
Create and review eCTD documents to support regulatory submission package.
Provide programming support for building integrated summary of safety/efficacy datasets and analysis.
Participate in the development and review of relevant SOPs.

What You Will Bring:

MS in Statistics, Computer Science or a related field with at least 8 years (or BS in Statistics, Computer Science or a related field with at least 10 years) of SAS programming experience in the pharmaceutical or biotech industry.
Proven experience of independently leading statistical programming activities for regulatory submissions.
Demonstrated ability to manage CRO relationships and oversee programmed deliverables.
Experience in providing statistical programming support to early and late phase clinical trials, and regulatory submissions (NDA, MAA).
Strong hands-on SAS programming skills.
In-depth knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
Experience in developing programming specifications, integrated summary safety/efficacy datasets and analysis, electronic submission data package in the eCTD format.
Familiar with statistical analysis methods and clinical data management concepts.
Deep Knowledge and experience with FDA and GCP/ICH regulations and guidelines.
Ability to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change.
Excellent written and verbal communication skills along with organizational and documentation skills.
Excellent attention to detail and problem-solving skills
Proven project management skills, professional attitude, self-improvement mentality with positive attitude

We encourage you to learn more about X4 Pharmaceuticals. Click on the links below!

About Us

Pipeline X4 Pharmaceuticals is an Equal Opportunity and Affirmative Action Employer committed to a culturally diverse workforce. All qualified candidates will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender identity or expression, sexual orientation, disability, veteran status, violence victim status or any other characteristic protected by law. Please note that effective January 1, 2022, as a condition of employment at X4 Pharmaceuticals, all employees and new hires must have received their complete dose of the COVID-19 vaccine, unless they have been granted an exemption.

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More about this job

Skills

Clinical trials
Regulatory compliance
SAS
Statistics
Process improvement
SAS/STAT
Reporting
Quality control
Computer science
Data management
Google Cloud
Communication skills
Documentation
Attention to detail
Problem solving
Project management

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