**Principal Biostatistician (Patient‑Reported Outcomes Focus)** _Remote- US | Full‑Time_ **About the Role** The Principal Biostatistician works independently across clinical trial projects of all complexity levels, including those with major regulatory impact. This position is highly visible within the organization and to external partners and is recognized as a statistical expert. The ideal candidate is a strong communicator, trusted advisor, and technical leader capable of driving statistical strategy and execution across multiple therapeutic areas.
**Key Accountabilities**
**Operational Execution**
+ Provide broad statistical support, including trial design, protocol development, and CRF development for assigned studies
+ Lead production and quality control of randomization schedules, statistical analysis plans, statistical reports, statistical sections of integrated clinical reports, and other supporting documentation
+ Perform sample-size calculations, generate randomization lists, and write statistical methodology sections for study protocols
+ Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and statistical analysis plans
+ Serve in a supporting role as a non‑voting independent statistician, preparing data and analyses for DMC review
+ This position is focusing on Patient-Report Outcomes (PRO)
**Business Development**
+ Support Business Development activities by contributing to study design discussions during internal and client meetings
+ Provide and explain sample‑size scenarios
+ Support proposal and budget development
+ Attend and prepare for bid defense meetings
**General Activities**
+ Understand regulatory requirements across therapeutic areas and their implications for statistical methods, processing, and analysis
+ Understand, apply, and provide training in extremely advanced and emerging statistical methods
+ Contribute to the development and delivery of internal and external statistical training seminars and courses
+ Review position papers in accordance with current good statistical practice
+ Interact with clients and regulatory authorities
+ Review publications and clinical study reports
+ Travel to and actively contribute in client meetings (e.g., discussing analysis concepts or presenting study results)
+ Perform additional responsibilities as defined by supervisor or manager
**Skills**
+ Strong analytical skills
+ Strong project management skills
+ Professional attitude with excellent attention to detail
+ Thorough understanding of statistical issues in clinical trials
+ Ability to clearly describe advanced statistical techniques and interpret results
+ Familiarity with regulatory and research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines)
+ Prior experience with SAS programming required
+ Ability to work independently
+ Strong mentoring and leadership skills
+ Strong business awareness and business development aptitude
**Knowledge & Experience**
+ PhD or MS in Statistics or related discipline with substantial experience
+ Knowledge of pharmacokinetic data is an advantage
+ Competent in written and oral English, in addition to local language
**Education**
+ PhD in Statistics or related discipline, **or**
+ MS in Statistics or related discipline
\#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$128k-178k yearly est. 9d ago
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Associate Director of Clinical Operations for Student Health
Oberlin College & Conservatory 3.9
Oberlin, OH
The Associate Director of Clinical Operations serves as a vital member of the Student Health Services leadership team at Oberlin College and Conservatory, overseeing the daily clinical and administrative operations that support student health, safety, and wellness. Working collaboratively under the supervision of the Director, the Associate Director ensures effective coordination of clinical workflows, compliance with healthcare regulations, and delivery of high-quality, student-centered care.
This position manages clinical systems, supervises nursing and support functions, supports policy development, and fosters a welcoming, inclusive, and compassionate environment that reflects the College's commitment to student wellbeing and holistic success.
The Associate Director of Clinical Operations of Student Health Services at Oberlin College and Conservatory is a full-time, 12-month Administrative and Professional Staff reporting to the Director of Student Health Services
Responsibilities
Administrative Leadership
* Assist the Director in planning, managing, and evaluating all aspects of Student Health Services operations.
* Oversee Medicat system administration, user access, and data management; collaborate with campus IT and Medicat representatives to enhance electronic health record (EHR) functionality (e.g., e-prescribing, online scheduling, appointment reminders).
* Serve as a clinical and administrative consultant to faculty, staff, students, and parents.
* Contribute to the development and implementation of departmental policies and procedures in compliance with accreditation standards, institutional policy, and local, state, and federal regulations.
* Support the Director in setting departmental goals, objectives, and assessment practices aligned with strategic planning and continuous quality improvement.
* Assist in crisis and emergency response coordination, including intervention and post-crisis follow-up for highly acute or critical incidents.
* Maintain accurate inventory and ensure safe storage of medical supplies, vaccines, and medications.
* Participate in public health surveillance, outbreak response, and infection control initiatives (e.g., flu and COVID-19 management).
* Ensure compliance with FERPA and HIPAA regulations for student health information confidentiality.
Clinical Nursing Care
* Perform triage, comprehensive nursing assessments, and collection of vital signs.
* Maintain an active clinical caseload providing direct nursing care to students.
* Administer medications, immunizations, and treatments per provider orders and standing protocols.
* Deliver first aid, wound care, and management of minor illnesses or injuries.
* Accurately document all clinical encounters and communications in the EHR.
* Provide health education and counseling on medication adherence, chronic disease management, and preventive care.
Case Management
* Coordinate continuity of care for students with complex or chronic medical, behavioral, or psychosocial needs.
* Develop and monitor individualized care plans in collaboration with medical, counseling, and case management staff.
* Track referrals, lab results, diagnostic imaging, and follow-up visits to ensure treatment adherence.
* Serve as liaison between students and off-campus healthcare providers, insurance networks, and specialists.
* Support coordination of academic accommodations, disability resources, and housing adjustments related to medical needs.
* Monitor compliance with institutional immunization and health clearance requirements.
Health Promotion and Campus Outreach
* Collaborate with the Office of Health Promotion to integrate individual care with campus-wide wellness initiatives that promote inclusion, prevention, and holistic wellbeing.
* Plan and implement campus health education programs, such as flu clinics, STI testing events, and wellness fairs.
* Partner with Residence Life, Counseling Services, Athletics, and other campus units to strengthen health promotion efforts.
* Develop and deliver workshops and presentations on health topics including stress management, sexual health, substance use, nutrition, and sleep hygiene.
* Create digital and print health education materials (e.g., brochures, newsletters, social media campaigns)
* Support and mentor peer health educators and student wellness ambassadors.
* Represent Student Health Services at orientations, wellness weeks, and community events.
Interdisciplinary Collaboration
* Collaborate with the Medical Director, Nurse Practitioners, Physicians, Physician Assistants, Mental Health Counselors, Case Managers, Campus Safety, and Student Affairs professionals.
* Participate in interdisciplinary case conferences and student support planning.
* Provide leadership during campus emergencies and coordinate crisis intervention when required.
Essential Job Functions Marginal Job Functions Required Qualifications
Education: Associate's or Bachelor's degree in Nursing (BSN preferred).
Licensure: Current Registered Nurse (RN) license in good standing in the State of Ohio.
Certifications: BLS/CPR required; ACLS, public health, or case management certification preferred.
Experience: Minimum of 2 years of clinical experience; college health, primary care, or community health experience preferred.
Desired Qualifications
Skills & Competencies:
* Demonstrated leadership and administrative capability in a healthcare setting.
* Excellent clinical judgment and organizational skills.
* Strong interpersonal and communication abilities with diverse populations.
* Proficiency in electronic medical records and Microsoft Office applications.
* Ability to manage multiple priorities and work collaboratively in a fast-paced, student-centered environment.
Quick Link for Posting *************************************** Compensation
Commensurate salary, based on knowledge and experience. Oberlin offers an excellent benefits package including 35 days of PTO (pro-rated for new hires).
Special Instructions to Applicants
$100k-123k yearly est. 60d+ ago
Clinical I.S. Analyst
Ashtabula County Medical Center 4.3
Ashtabula, OH
MINIMUM QUALIFICATIONS * Education, Knowledge, Skills and Abilities Strong analytical and technical expertise in clinical informatics, with demonstrated proficiency in clinical and business applications including Epic EMR and Microsoft Office. Skilled in clinical workflow analysis, observing end users to identify gaps, inefficiencies, and safety risks, and redesigning processes to optimize usability, enhance productivity, and improve patient care outcomes. Experienced in Epic system configuration, support, and troubleshooting with a strong understanding of the clinical context in which systems are used. Possesses comprehensive knowledge of enterprise clinical systems and collaborates effectively with clinical, IT, and operational stakeholders to resolve issues, support adoption, and drive continuous improvement.
* Required Length and Type of Experience
* Three years of healthcare experience supporting clinical systems. Desired 2- or 4-year degree, Clinical training preferred but not required.
* Required Licensure or Certification
N/A
* Required Physical and Environmental Demands
* Physical stamina to travel between hospitals in inclement weather.
Ability to lift 20 lbs.
* Mental concentration to multi-task and work within aggressive deadlines.
GENERAL SUMMARY
This position provides analytical, clinical, and resource management system support for our organization's healthcare clinical applications. The position provides support to hospital managers, nurses and providers and advises the end users on the use of technology to attain operational efficiencies. This position will participate in the evaluation, planning, reporting, testing, implementation and support of the ARMC Healthcare System healthcare clinical applications. This position maintains a role as a dedicated physician support role for EMR, being a key representative and first contact in direct physician support and nursing as needed, ARMC physician personalization training as needed.
Benefits
* Competitive salary package
* Extensive benefit package including medical, dental, vision, and life insurance (Benefits on Day 1!)
* Accident & critical illness insurance
* Tuition Reimbursement
* Short-Term & Long-Term Disability Insurance
* Paid Maternity Leave
* Employee Assistance Program
* Paid Time Off
* Employee Wellness Plan that pays you for being healthy
* 403(b) and Roth Retirement Plan with company matching
* We are a qualifying employer for the Public Service Loan Forgiveness (PSLF) Program which allows you to receive forgiveness of the remaining balance of your Direct Loans after you have made 120 qualifying monthly payments while working full-time for a qualifying employer
Benefits
* Competitive salary package
* Extensive benefit package including medical, dental, vision, and life insurance (Benefits on Day 1!)
* Accident & critical illness insurance
* Tuition Reimbursement
* Short-Term & Long-Term Disability Insurance
* Paid Maternity Leave
* Employee Assistance Program
* Paid Time Off
* Employee Wellness Plan that pays you for being healthy
* 403(b) and Roth Retirement Plan with company matching
* We are a qualifying employer for the Public Service Loan Forgiveness (PSLF) Program which allows you to receive forgiveness of the remaining balance of your Direct Loans after you have made 120 qualifying monthly payments while working full-time for a qualifying employer
$74k-94k yearly est. 15d ago
Pulmonology Clinic APP - Mansfield
Ohio Health 3.3
Mansfield, OH
We are more than a health system. We are a belief system. We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more - in our careers and in our communities.
Summary:
M-F
No Weekends or Holidays
The ideal candidate will have critical care experience
The Advanced Practice Provider (APP), Physician Assistant (PA) or Advanced Practice Registered Nurse (APRN), including Clinical Nurse Specialist (CNS) or Nurse Practitioner (NP), work in collaboration with the physician primarily in the outpatient setting caring for acute, chronically ill or injured patients. Responsibilities will vary depending on specialty.
Responsibilities And Duties:
Works under direction and in consultation/collaboration with physician and may perform services authorized by the supervising/collaborating physician that are part of the physician's normal course of practice and expertise. Promotes quality outcomes and initiatives. Must have a Supervision Agreement (SA) or Standard Care Arrangement (SCA) with a physician in like practice. Practices within applicable state laws, appropriate boards, and in accordance with his/her/their SA/SCA and delineation of privileges.
Minimum Qualifications:
Master's Degree (Required) AANP - American Association of Nurse Practitioners - American Association of Nurse Practitioners Certification Board, APRN - Advanced Practice Registered Nurse License - State of Ohio Board of Nursing, NCCPA - National Commission on Certification of Physician Assistants - American Association of Physician Assistants, PA - Physician Assistant - National Commission on the Certification of Physician Assistants
Additional Job Description:
MINIMUM QUALIFICATIONS
Must have a current Physician Assistant License to practice in Ohio and maintain this from the State Medical Board of Ohio. Must have and maintain a current Certification from the national certifying body National Commission on Certification of Physician Assistants (NCCPA).
OR
Must have a current APRN license to practice from the Ohio Board of Nursing and maintain this licensure from the State Nursing Board of Ohio. Must have and maintain current Certification from a national certifying body American Nurses Credentialing Center (ANCC), American Association of Nurse Practitioners (AANP), or American Association of Critical-Care Nurses (AACN).
Work Shift:
Day
Scheduled Weekly Hours :
40
Department
Mansfield Pulmonary
Join us!
... if your passion is to work in a caring environment
... if you believe that learning is a life-long process
... if you strive for excellence and want to be among the best in the healthcare industry
Equal Employment Opportunity
OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment
$83k-110k yearly est. Auto-Apply 2d ago
Pulmonology Clinic APP - Mansfield
Ohiohealth 4.3
Mansfield, OH
**We are more than a health system. We are a belief system.** We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further to help people uncover their own power to be healthy. We inspire hope. We learn, grow, and achieve more - in our careers and in our communities.
** Summary:**
M-F
No Weekends or Holidays
The ideal candidate will have critical care experience
The Advanced Practice Provider (APP), Physician Assistant (PA) or Advanced Practice Registered Nurse (APRN), including Clinical Nurse Specialist (CNS) or Nurse Practitioner (NP), work in collaboration with the physician primarily in the outpatient setting caring for acute, chronically ill or injured patients. Responsibilities will vary depending on specialty.
**Responsibilities And Duties:**
Works under direction and in consultation/collaboration with physician and may perform services authorized by the supervising/collaborating physician that are part of the physician's normal course of practice and expertise. Promotes quality outcomes and initiatives. Must have a Supervision Agreement (SA) or Standard Care Arrangement (SCA) with a physician in like practice. Practices within applicable state laws, appropriate boards, and in accordance with his/her/their SA/SCA and delineation of privileges.
**Minimum Qualifications:**
Master's Degree (Required) AANP - American Association of Nurse Practitioners - American Association of Nurse Practitioners Certification Board, APRN - Advanced Practice Registered Nurse License - State of Ohio Board of Nursing, NCCPA - National Commission on Certification of Physician Assistants - American Association of Physician Assistants, PA - Physician Assistant - National Commission on the Certification of Physician Assistants
**Additional Job Description:**
**MINIMUM QUALIFICATIONS**
Must have a current Physician Assistant License to practice in Ohio and maintain this from the State Medical Board of Ohio. Must have and maintain a current Certification from the national certifying body National Commission on Certification of Physician Assistants (NCCPA).
**OR**
Must have a current APRN license to practice from the Ohio Board of Nursing and maintain this licensure from the State Nursing Board of Ohio. Must have and maintain current Certification from a national certifying body American Nurses Credentialing Center (ANCC), American Association of Nurse Practitioners (AANP), or American Association of Critical-Care Nurses (AACN).
**Work Shift:**
Day
**Scheduled Weekly Hours :**
40
**Department**
Mansfield Pulmonary
Join us!
... if your passion is to work in a caring environment
... if you believe that learning is a life-long process
... if you strive for excellence and want to be among the best in the healthcare industry
Equal Employment Opportunity
OhioHealth is an equal opportunity employer and fully supports and maintains compliance with all state, federal, and local regulations. OhioHealth does not discriminate against associates or applicants because of race, color, genetic information, religion, sex, sexual orientation, gender identity or expression, age, ancestry, national origin, veteran status, military status, pregnancy, disability, marital status, familial status, or other characteristics protected by law. Equal employment is extended to all person in all aspects of the associate-employer relationship including recruitment, hiring, training, promotion, transfer, compensation, discipline, reduction in staff, termination, assignment of benefits, and any other term or condition of employment