Durham, North Carolina, United States · Remote OK
$88k–$174k/yr
Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who ta…
Skills: Statistical Consultancy, Clinical Trial Design, SAS Programming, CDISC Standards, SDTM
Raleigh, North Carolina, United States · On-site
At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advanc…
Skills: OB/GYN Ultrasound, Fetal Wellbeing Assessment, Amniocentesis Assistance, CVS Procedures Assistance, Saline Infusion Sonography
Raleigh, North Carolina, United States · Remote OK
$76k–$200k/yr
ROLE SUMMARY Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is innov…
Skills: Territory Management, Product Promotion, Customer Engagement, Business Acumen, Analytical Skills
Southport, North Carolina, United States · Remote OK
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical de…
Skills: Clinical Data Management, Project Leadership, Cross-functional Collaboration, Risk Mitigation, Quality Management
Wilmington, North Carolina, United States · Hybrid
At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven r…
Skills: Project Management, Contract Management, Budgeting, Risk Management, FDA Regulations
Charlotte, North Carolina, United States · On-site
$45/hr–$76/hr
We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate…
Skills: Drug Screening, Dispensing Services, Sterile IV Preparation, Inventory Management, DEA Regulations
Pittsboro, North Carolina, United States · Hybrid
$90k–$120k/yr
Xyzagen (ZiZaGen) is seeking a highly skilled scientist with a background in Pharmaceutical Sciences and extensive experience in immunoassay development and validation to lead our Small and Large Molecule Bioanalysis eff…
Skills: LC-MS/MS, ELISA, Immunoassay Development, Assay Validation, GxP Compliance
Riegelwood, North Carolina, United States · On-site
Job Title: Chemical Operator, alternating days/nights, 12 hour shift/7 day off rotation Job Description: The Role: Our site in Riegelwood, NC is seeking a Chemical Operator II to join our team. In this role, you will be …
Skills: Chemical Operation, Forklift Operation, Sampling, Distillation, Vacuum Distillation
Durham, North Carolina, United States · On-site
$55k–$94k/yr
Join Durham County Government Durham County Government is home to over 2,000 dedicated professionals working together to deliver essential services that strengthen and support our vibrant, diverse community. As the heart…
Skills: Public Health Education, Program Planning, Program Evaluation, Interpersonal Communication, HIV/AIDS Coordination
Winston-Salem, North Carolina, United States · On-site
$26/hr–$39/hr
Department: 35102 Wake Forest University Health Sciences - Pediatrics Status: Full time Benefits Eligible: Yes Hours Per Week: 40 Schedule Details/Additional Information: Monday through Friday8am to 5pmOccasional nights …
Skills: Interpersonal Communication, Oral Communication, Written Communication, Reading Comprehension, Organizational Skills
Winston-Salem, North Carolina, United States · On-site
Responsibilities: • Responsible for preparing the donor, donor area and equipment for the pheresis process. • Prepares the autopheresis machine for the pheresis process. • Monitors the donor and the pheresis process, res…
Skills: Pheresis Process, Donor Support, Medical Equipment Operation, Bilingual English/Spanish, Data Recording
Durham, North Carolina, United States · Hybrid
$90k–$112k/yr
Join Butterfly Effects - Where BCBAs Lead Board Certified Behavior Analyst (BCBA) - Hybrid In Home Based in Chapel Hill - Durham, NC Set your own schedule Are you a passionate BCBA seeking a rewarding career where your e…
Skills: Applied Behavior Analysis, Functional Behavior Assessments, Treatment Planning, Caregiver Training, Clinical Supervision
Charlotte, North Carolina, United States · Hybrid
Job Description Join us to create change and have an impact in homes around the world. At Electrolux, a leading global appliance company, we strive every day to shape living for the better for our consumers, our people, …
Skills: Consumer Insights, Market Research, Qualitative Research, Quantitative Research, Strategic Thinking
Huntersville, North Carolina, United States · On-site
Job DetailsJob Location: Discovery Place KIDS-Huntersville - Huntersville, NC 28078Position Type: Part TimeEducation Level: 4 Year DegreeTravel Percentage: NoneJob Shift: Week days and weekendsJob Category: Nonprofit - S…
Skills: Guest Experience, Public Speaking, Informal Education, Cash Handling, Point-of-Sale Systems
Mocksville, North Carolina, United States · On-site
Job DetailsJob Location: Mocksville, NC 27028Position Type: Full TimeEducation Level: 4 Year DegreeTravel Percentage: NoneJob Shift: DayJob Category: EngineeringEssential Duties & Responsibilities: Process Development an…
Skills: Plastics Processing, Process Optimization, Root Cause Analysis, FMEA, Process Simulation Software
Holly Springs, North Carolina, United States · On-site
Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facil…
Skills: Instrumentation & Controls, Automation Systems, Metrology, cGMP, FDA Regulations
Winston-Salem, North Carolina, United States · On-site
Overview POSITION SUMMARY STATEMENT: The Chemistry Supervisor is responsible for monitoring and guiding day to day testing activities in the Quality Control laboratory. The Supervisor works with and trains Analysts and T…
Skills: Analytical Chemistry, Laboratory Management, cGMP Compliance, ISO 17025, OOS Investigations
Holly Springs, North Carolina, United States · On-site
Career CategoryEngineeringJob Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with seriou…
Skills: Emerson DeltaV, Distributed Control System (DCS), Process Automation, Computerized Systems Validation, Data Integrity Assessments
Durham, North Carolina, United States · On-site
At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advanc…
Skills: Pharmaceutical Care, Medication Therapy Management, Pharmacokinetics, Drug Information, Patient Education
Durham, North Carolina, United States · On-site
$126k–$351k/yr
Overview Customer dedicated Clinical Project Management Director taking an Indication Director role to provide operational delivery oversight for select indication(s). Provides strategic and operational leadership for in…
Skills: Clinical Project Management, Strategic Leadership, Risk Management, Cross-functional Team Leadership, Resource Planning
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Independently manage statistical project support and provide expert consultancy for clinical trial designs and analysis plans. Develop and run SAS programs for data reporting while ensuring compliance with regulatory standards like FDA and ICH.
Requires a Master's degree in mathematics, statistics, or a related field with a strong statistical component. Candidates must have a minimum of 3 years of experience leading clinical trial projects and data analysis.
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
Independently manages statistical project support and provides expert statistical consultancy across the stats function.
What you will do
Manage the statistics support to one or more projects/sponsor programs of work, ensuring that needs are met by expert and timely statistical consultancy and support
Provides expert review of study designs, analysis plans, and reports
Assist sponsors in the design of clinical trials, including statistical sections of the study protocol, randomization methodology, and writing statistical analysis plans
Consult with internal departments, sponsors, and other third parties regarding statistical issues and reporting requirements
Provide project support to the statistics reporting process through the specification/review of tables, figures, and listings shells, writing/review of derived dataset specifications, and the formatting of report documents and tabulations
Undertake the preparation of final reports, including the production of tables, listings, and figures, and report writing
Develop, evaluate, and run Statistical Analysis System (SAS) programs for the statistical analysis and reporting of clinical study data. This includes programs for derived datasets, Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM), and Analysis Data Model (ADaM) datasets, tables, figures, and listings, and their validation
Ensure the maintenance of documentation, e.g., the description of programs and validation
Produce ad hoc data summaries when requested during a trial.
Extract information from the system during a trial, e.g., summaries, data listings, study data sets.
Validate software, in the role of system owner or tester, and test SAS Macros, maintaining the required validation and testing documentation
Make statistical contributions to manuscripts for publication/presentation
Provide support for the bidding process, including contribution to budget review, proposals, and bid defense meetings
Lead the identification of system and process improvements, and develop and implement solutions to improve the efficiency and quality of clinical study data processing and reporting
Support the development of statistical design and analysis policies
Maintain knowledge in design consultancy and analysis methodology, statistical software packages (e.g., SAS and nQuery), and regulatory guidance documents, e.g. International Council for Harmonization (ICH), Food and Drug Administration (FDA), and Committee for Medicinal Products (CPMP) points to consider
Assist with Quality Assurance and Audit requirements
Assist the Director of Biostatistics with all other aspects of the job as required
Perform all activities in compliance with Worldwide Clinical Trials and agreed sponsor quality system standards, relevant ICH standards, and specifically with FDA Quality System Regulation (including 21CFR Part 11)
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
What you bring to the role:
Computer literate and numerate with a proven ability to adapt to various computer systems
Expert-level project statistician experienced in providing statistical leadership to projects
Design and analysis consultancy skills and knowledge across a broad range of applications, together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating, influencing, and embracing innovation and change
Master's level in mathematics, statistics, or another subject required with a strong statistical component
Minimum 3 years of statistical experience leading clinical trial projects and data analysis
At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation.
The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):
The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
Worldwide Clinical Trials (Worldwide) is a global CRO serving development-driven biopharmaceutical companies, with more than 4,400 professionals operating across more than 70 countries. The company delivers therapeutically dedicated expertise in neuroscience, oncology, rare disease, and internal medicine, with comprehensive support across every development phase – from early-stage and first-in-human studies through Phase III registration trials. The company's flexible service model – spanning full-service trial management to functional service partnerships through Worldwide Flex – is powered by a people first, partnership driven outsourcing approach that strengthens collaboration, enhances data transparency, and supports more informed decision making. This provides sponsors with tailored, adaptable solutions that keep pace with the evolving demands of clinical research. Learn more at www.worldwide.com
Offices: 600 Park Offices Drive, Suite 200, Research Triangle Park, NC 27709, US · 2455 Northeast Loop 410, Suite 150, San Antonio, TX 78217, US · 4509 Freidrich Lane, Building 2, Suite 200, Southpark Commerce Center Two, Austin, TX 78754, US · 245 First Street Riverview II, Suite 1847, Cambridge, MA 02142, US · 4.1 Manuel Ugarte 2110, CABA, Buenos Aires, 1428, AR
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