Senior Biostatistician
CPC Clinical Research
Key Responsibilities
Leadership & Project Oversight- Serve as the lead biostatistician on clinical study teams, accountable for statistical deliverables, quality, and timelines.
- Provide mentorship and oversight to statisticians and statistical programmers.
- Communicate project progress, risks, and resource needs to leadership.
- Ensure alignment of project execution with departmental and organizational goals.
- Lead the statistical design of clinical studies, including protocol development and statistical methodologies.
- Perform and review sample size and power calculations.
- Develop, review, and finalize statistical analysis plans (SAPs).
- Recommend innovative statistical approaches, endpoints, and reporting strategies aligned with study objectives.
- Provide statistical input into electronic data capture (EDC) design.
- Partner with data management to define edit checks and ensure high-quality data collection.
- Ensure study data supports interim and final analyses and regulatory requirements.
- Develop, validate, or oversee statistical programming using SAS and other tools (e.g., R, Python).
- Review outputs for accuracy, quality, and compliance with standards.
- Guide programming specifications, table shells, and reporting frameworks.
- Lead preparation and review of interim analyses, final study reports, and regulatory submissions.
- Contribute to manuscripts, abstracts, integrated summaries, and ad hoc analyses.
- Communicate complex statistical concepts and results to non-statistical stakeholders and senior leadership.
- Ensure compliance with GCP, FDA, ICH, and other applicable regulatory standards.
- Maintain audit-ready documentation and high-quality, submission-ready deliverables.
- Contribute to the development and refinement of statistical SOPs and best practices.
- Collaborate with clinical operations, data management, physicians, and external partners.
- Interface with regulatory agencies, data monitoring committees, and steering committees.
- Build strong client relationships and support business development initiatives.
- Provide statistical consulting across therapeutic and technical domains.
- Support specialized activities such as randomization design, unblinded statistician roles, and integrated summaries of safety and efficacy.
- Represent the organization through publications, conference participation, and professional engagement.
- PhD or Master's degree in Biostatistics, Statistics, or related field with at least 5 years of experience in clinical trial data analysis
- Demonstrated programming proficiency in SAS (version 9.0 or higher)
- Experience supporting Phase I-III clinical trials
- Strong knowledge of ICH guidelines and regulatory requirements; familiarity with FDA submission processes
- Familiarity with CDISC standards (e.g., SDTM, ADaM) for regulatory submissions
- Proven leadership experience managing projects and mentoring team members
- Proficiency with Microsoft Office tools (Word, Excel, PowerPoint)
- Experience working on integrated summaries of safety and efficacy (ISS/ISE) or similar large-scale reporting efforts
- Strong analytical, organizational, and problem-solving skills with high attention to detail
- Excellent communication and interpersonal skills, with the ability to convey complex statistical concepts clearly
- Ability to manage multiple trials and priorities simultaneously with minimal disruption to productivity
- Experience with FDA/NDA submissions and regulatory interactions
- Experience working in a client-facing or CRO environment
- Therapeutic area expertise
- Proficiency in R, Python, or other advanced analytical tools
- Track record of contributions to publications, abstracts, or conference presentations
- Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
- Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
- 11 paid holidays
- 15 - 25 vacation days based on years of service
- Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
- Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
- Flexible and remote work schedules
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior Biostatistician in Aurora, CO vacancy
- ...our recruiters can quickly match you with suitable roles when they arise. Location: Various locations across Colorado Biostatisticians apply statistical methods to analyze health data and support public health research. Key Responsibilities: Design...Suggested
$90 - $131.5 per hour
Position Senior Principal Systems Engineer – on site in Aurora, CO. Location & Terms W2 hourly contract. Salary ranges from $90 to $131.50 per hour, depending on experience and benefits package. Clearance TS/SCI Clearance required. Responsibilities Elaborate...SeniorHourly payContract work$60 - $70 per hour
...Job Description A Higher Education client of Insight Global is seeking a Senior Data Engineer with at least seven years of experience designing, building, and supporting modern enterprise data platforms. This individual will be responsible for designing, developing, and...SeniorContract work$146k - $175k
...clearance. Applicants that do not meet these requirements will not be considered. SciTec has an immediate opportunity for a talented Senior Datacenter Engineer to join our team in Boulder, CO. Successful applicants will bring deep experience with data center design,...SeniorTemporary workWork experience placementImmediate startFlexible hours$26.25 - $33.65 per hour
Key Responsibilities: * Act as the point of escalation for L1 Systems Analyst. * Deliver advanced workstation support. * Provide advanced customer specific application support. * Troubleshoot advanced network connectivity and devices/user connectivity. * Administer...SeniorFull timeShift work$172.5k - $215.5k
...SCI security Clearance. Candidates who do not hold this clearance are not eligible for hire. Solidus is seeking a highly skilled Senior Principal Systems Engineer to join a flagship program within our Space Intelligence, Surveillance, and Reconnaissance (SISR)...SeniorContract workLocal area$132.4k - $251.6k
Location: US-MA-TEWKSBURY-TB1 ~ 50 Apple Hill Dr ~ ASSABET BLDG Date Posted: 2026-07-02 Position: Model-Based Systems Engineer (MBSE) Engagements Subject Matter Expert (SME) U.S. Citizen, U.S. Person, or Immigration Status Requirements: Active and transferable U.S. government...SeniorContract workTemporary workRelocation packageFlexible hours- ...Senior Director, Principal Gifts About the Company Philanthropic organization supporting Indigenous culture & individuals Industry Non-Profit Organization Management Type Non Profit Founded 2017 Employees 11-50 Categories...Senior
- ...Kärcher in Aurora, CO seeks a senior e-commerce leader to drive our Amazon presence and other key marketplaces. You will lead strategic planning, set ambitious sales goals, and work with content teams to optimize product descriptions and search rankings. You will manage...Senior
- Bank of America is seeking a motivated individual to connect clients with financial solutions aimed at achieving their goals. The role requires understanding clients' needs through in-person or inbound call interactions, focusing on service requests and building strong...Senior
- ...Chimera in Colorado is seeking a Senior Program Control Analyst to provide expert budget, acquisition, and financial management support for OPIR and persistent GEOINT programs. You will partner with program managers and government analysts to defend budget strategies,...Senior
$169.88k - $209.85k
...Akebia is looking for a Senior Medical Science Liaison to support its products and therapeutic areas focused on chronic kidney disease (CKD). This field-based role requires advanced clinical or medical degrees and a minimum of 3 years MSL experience in nephrology. You...Senior- A leading technology solutions company in Aurora, Colorado seeks an experienced Enterprise Program Manager to oversee management for three locations. You will coordinate program activities, manage customer expectations, and ensure compliance with contract requirements....SeniorContract work
- Cherry Creek Retirement Village is seeking a Transportation Coordinator/Driver CDL Class C with P Endorsement for a part-time role at about 20 hours per week. The position loads, transports, and unloads residents for errands, medical appointments, and activities in compliance...SeniorPart time
- Software engineers are responsible for the complete life cycle of a new or modified software product, from research and design to implementation, training and support. Essential Duties: * Designs, modifies, develops, writes and implements software programming applications...SeniorFull time
- Trinnex is seeking a Senior Cyber Security Analyst to enhance the security of software systems supporting water utilities. You will focus on securing the software development lifecycle, ensuring systems are resilient against evolving threats. This position involves conducting...Senior
$110k - $149k
A leading electrical contractor in Colorado is seeking an experienced General Superintendent to oversee field operations across multiple electrical construction projects. The ideal candidate will have over 10 years of experience in electrical construction and strong leadership...SeniorFor contractors- ...Senior Geospatial Data EngineerUS CO DenverI certify that answers given herein, and on any attachment (hereafter, the “Application”), are true and complete to the best of my knowledge and belief. I authorize the investigation of all statements contained in the Application...Senior
- Contract Type : W2 Long-term contract with benefits. Possibility of extension or conversion to FTE. Why this role matters Join a high‑impact analytics team that helps our client understand competitor moves in mobile and telecom. You’ll explore large datasets, uncover signals...SeniorLong term contractContract workFor contractors
- Junior Procurement Specialist with Security Clearance Cencore Group The Junior Procurement Specialist supports the Lead Procurement Specialist / Procurement Manager with day-to-day procurement, logistics, and materials coordination activities. This role helps ensure ...Senior
- Job Title Job Description Help Perform mathematical work assignments involving a segment of a scientific area, or applied field of mathematics. Apply general scientific theories, and principles of mathematics, as well as the full range of methods, procedures...
- ...Raytheon in Aurora, Colorado, is seeking a Senior Systems Engineer to join our on-site team at Buckley SFB. You will respond to anomalies, monitor system status, and support customers and contractors, ensuring smooth operation of a complex system. The role requires a...SeniorFor contractors
- Job Overview: We are seeking a skilled professional with strong expertise in SQL, Python, Spark, and leading AI/ML frameworks to design and build scalable, intelligent data solutions. The ideal candidate will have hands‑on experience with big data platforms and distributed...Senior
$90k - $102k
...Senior Data Governance Analyst Within our Corporate Finance team located in Denver, Leprino is seeking a Senior Data Governance Analyst (Master Data) to guide how master data is structured, governed, and applied across the business. This highly visible role defines...SeniorLocal area- Job Description A reputable Public Accounting firm in the area is looking to add a Tax Director to their team. This stable and growing firm offers clients valuable knowledge and expertise in tax. Due to the recent growth of the firm, there is an opportunity for ...SeniorLocal area
$104k - $150k
...can truly know and help our clients, communities, and each other. About the role: CLA is looking to hire a Data Analyst Senior; you will make use of the Microsoft Power Platform, or a scripting language like R or Python. The Data Analyst Senior cleans up data...Senior$73.45k - $91.79k
JE Dunn in Aurora, CO, is seeking an Equipment Operations Specialist to support day-to-day operations for Blue Hat Crane & Equipment Rental. This role involves managing customer interactions, scheduling, and accurate billing relevant to our equipment operations. The ideal...Senior- ...Job Description Audit Senior - Denver, CO Who: Experienced public accounting professionals with 2+ years of audit experience who are looking to specialize, grow their careers, and become trusted business advisors. What: Deliver industry-focused audit and assurance...SeniorFull timeWork at office
- Baylor Scott & White Health seeks an Analytics Developer to improve digital assets' analytics and reporting. This position will be key in developing and implementing metrics for tracking in PowerBI, as well as performing requirements definition and ad-hoc reporting. The...Senior
- ...technical design and end-to-end delivery of complex data-driven solutions and data products for the enterprise. The Data Engineer, Senior will report to the Sr Manager, Data Solutions / Manager. This role is responsible for independent designing, building, and operating...Senior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Biostatistician. Be the first to apply!
Related searches
- senior medical science liaison Aurora, CO
- senior accountant remote Aurora, CO
- senior robotics software engineer Aurora, CO
- senior compensation manager Aurora, CO
- senior storage engineer Aurora, CO
- senior vice president of operations Aurora, CO
- senior level Aurora, CO
- senior tableau developer Aurora, CO
- senior magento developer Aurora, CO
- senior vmware engineer Aurora, CO

