Qualified and experienced epidemiologist and biostatistician, currently working as freelancer. Over 20 years of experience in medical statistics, epidemiology (clinical and environmental), health economics and outcomes research (HEOR), patient-reported outcomes (PROs) validation and data management (clinical and observational data, cancer registries, population statistics) — with good knowledge of statistical software as SAS, R and STATA.

Quality professional with broad experience from clinical to commercial settings. Adept in compliance, systems admin, operations, consent decree remediation, risk assessments, hosting/performing GMP audits, managing regulatory inspections and CMC Quality oversight for oral solids, sterile(s), biologics and cell/gene therapy. Specialize in startup operations, deploying phase appropriate, science based and regulatory compliant processes and systems. Team player with over 20+ year record of building consensus and implementing value added changes.

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Octa Consulting Services partner with pharma companies along the drug development process offering both a bird’s-eye view of the molecule’s journey and a granular focus on statistical methodology. With tailored and researched statistical applications, we offer peace of mind from Clinical Development Plan (CDP) development to regulatory success, affording our pharma clients the freedom to challenge and push their own expectations.

Voice of the Customer Analysis- Upcoming Biometrics Software Release

Accomplished executive with broad pharmaceutical, biotechnology, and CRO experience, holding key leadership positions within Quality Assurance, Clinical Operations, and Data Management functions. Extensive experience in conducting, supervising and managing quality assurance audits(GxP) and assessments, effectively managing auditing teams and consistently exceeding performance objectives. Strong record of successfully guiding and coordinating the efforts of R&D, Quality Assurance, Clinical Operations, Clinical Data Management, IT, and other support areas to achieve success, both domestically and internationally.

Independent clinical consultant with over 24 years of clinical trials experience in project management, QA and GCP/ICH auditing, and team/trials management throughout the United States, Western/Central/Eastern Europe, Australia and Canada. Strong experience managing and auditing trials in oncology, ophthalmology, bariatric surgery, and cardiology; pharmaceutical studies in plastic surgery, hematology, obesity, CNS, smoking cessation, anesthesiology, renal disease/dialysis, hepatology, and uremic pruritis; biologic studies in oncology, rheumatoid arthritis, psoriasis, and hypertrophic scarring.

Safety Scientist

Medical Communications Writer needed to attend and write the executive summary for an executive meeting of the American Society of Echocardiography  taking place in Washington DC the morning of Tuesday, June 27.  Someone local or within driving distance to both DC and NY- if successful, this engagement will most likely be repeated in March in NY for a much bigger ASE event.  ASE would prefer to be able to use the same writer for both events if possible.   The ideal…

Approximately 80 pages of a study report, to be submitted in 510K.  Final draft expected to be available April 15, looking for a QC completion date of May 1.  Report will be provided electronically.  Content QC required- checking study report body content against tables listings and figures.  Formatting QC most likely not needed- to verify.  Extent of QC- to be discussed.   Will either be 100% QC or risk based (random 10%, N-1 or other).  The study itself was 80 patients,…

.I am a Biostatistician with more than 30 years of experience in clinical research

Jennifer M. Hayes is a highly accomplished and experienced Medical Affairs professional with over 21 years of experience in the hospital & healthcare, and life science industries. As a recognized leader in the field of infectious diseases, Jennifer has demonstrated exceptional leadership skills, effectively managing teams and achieving company goals. Her extensive expertise in medical affairs has allowed her to successfully manage and oversee a variety of projects and initiatives. With a career spanning multiple companies and roles, Jennifer has…

Statistical Programming

Ophirex Statistical Programmer- DP

Ophirex Statistical Programmer- UP

Ophirex Biostatistician

.CMC, MANUFACTURING & PROCESS DEVELOPMENT:

My personal vision is to ensure that payers, physicians, and patients have the right evidence

at the right time in the right format to make the right decisions for the benefit of patients. My

professional activities all support this long-term vision.

As a statistician with 20+ years experience in healthcare (academia, pharmaceutical

companies and service…

15 years experience in strategy and management consulting and leadershipExperience in data science and AI strategy, transformation and roadmap developmentExperience in providing strategic direction and leading technology delivery programsExperience leading funding proposal efforts with a portfolio estimate of up to $150 millionExperience in strategy and planning, governance, developing and maintaining relationships with team, stakeholders and clientsExperience managing teams (data science, program managers, software engineers)Experience hiring and leading teams, including remote, distributed teams and vendors