Title: Head of Biostatistics & Programming (Clinical Research Organization) Location: United States Job Id: 169656 Job Description: Piper Companies is seeking a Global Head of Biostatistics & Programming to join a leading Clinical Research Organization (CRO). The Global Head of Biostatistics & Programming will provide executive leadership for a global biostatistics organization, driving strategic growth, operational excellence, client engagement, and financial performance. This role is ideal for a senior biostatistics leader with strong commercial acumen, global team leadership experience, and a proven track record of business growth within the life sciences industry. Responsibilities of the Global Head of Biostatistics & Programming: - Define and execute the global biostatistics strategy aligned with business growth objectives. - Own full P&L responsibility, including revenue growth, forecasting, profitability, and resource planning. - Partner with business development teams on proposals, bid defenses, and client engagements. - Lead a global biostatistics organization, ensuring quality, scalability, and delivery excellence. - Oversee operational metrics, workforce planning, and performance management initiatives. - Ensure compliance with global regulatory standards including FDA, EMA, PMDA, and ICH. - Serve as an executive sponsor for strategic client relationships and key accounts. - Build and develop a high-performing global leadership team. Requirements of the Global Head of Biostatistics & Programming: - PhD or MSc in Biostatistics, Statistics, Mathematics, or a related field. - 15+ years of biostatistics experience within CRO, pharmaceutical, biotechnology, or life sciences organizations. - Experience leading large global teams across multiple regions. - Proven P&L ownership and business growth experience. - Strong understanding of clinical development, statistical methodologies, and regulatory requirements. - Executive-level leadership experience with strong client-facing and commercial expertise. Compensation for the Global Head of Biostatistics & Programming: - $275,000 - $350,000 base salary - Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law. Keywords: Global Head of Biostatistics, Biostatistics Leadership, CRO, Clinical Research Organization, Executive Leadership, P&L Ownership, Clinical Development, Drug Development, Statistical Strategy, Data Science, Regulatory Compliance, FDA, EMA, PMDA, ICH, Clinical Trials, Business Development, Client Engagement, Global Operations, Life Sciences, Commercial Strategy, Revenue Growth, Global Team Leadership, statistical programming, programming, biostats, biostatistics #LI-AG1 #REMOTE

Title: Biostatistician Location: Silver Spring United States Job Description: Overview Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices. Summary: We are seeking a qualified Biostatistician to provide statistical and clinical trial support for a Phase II clinical research effort supporting the Walter Reed Army Institute of Research (WRAIR). The selected candidate will support regulatory-focused statistical analysis activities, including CDISC-aligned deliverables and study closeout support associated with FDA submission requirements. Responsibilities Essential Job Functions: - Perform statistical analyses in accordance with approved Statistical Analysis Plans (SAPs) - Support development, review, and validation of CDISC-compliant deliverables, including: - SDTM datasets - ADaM datasets - Define.xml documentation - SDRG/ADRG documentation - Generate and validate Tables, Listings, and Figures (TLFs) - Conduct data cleaning, quality control, and statistical validation activities - Support clinical study closeout and regulatory submission activities - Coordinate with clinical research and project teams to support data review and analysis workflows - Prepare technical documentation and contribute to study reports and presentations - Participate in project status meetings and provide progress updates Qualifications Necessary Skills and Knowledge: - Perform statistical analyses in accordance with approved Statistical Analysis Plans (SAPs) - Support development, review, and validation of CDISC-compliant deliverables, including: - SDTM datasets - ADaM datasets - Define.xml documentation - SDRG/ADRG documentation - Generate and validate Tables, Listings, and Figures (TLFs) - Conduct data cleaning, quality control, and statistical validation activities - Support clinical study closeout and regulatory submission activities - Coordinate with clinical research and project teams to support data review and analysis workflows - Prepare technical documentation and contribute to study reports and presentations - Participate in project status meetings and provide progress updates Minimum Qualifications: - Master's degree or higher in Biostatistics, Epidemiology, Statistics, Public Health, or related field - Experience supporting clinical research or clinical trial studies - Experience developing or executing Statistical Analysis Plans (SAPs) - Experience with statistical programming and analysis using SAS, R, STATA, or similar tools - Experience generating statistical outputs including Tables, Listings, and Figures (TLFs) - Strong understanding of data validation, quality control, and analytical workflows - Ability to work independently and collaboratively in cross-functional scientific environments - Strong written and verbal communication skills - Able to to successfully complete a background investigation and satisfy Government access requirements prior to beginning work. Preferred Qualifications: - Experience supporting FDA-regulated clinical trials - Hands-on experience with CDISC standards, including SDTM and ADaM - Experience preparing Define.xml, SDRG, and ADRG documentation - Experience supporting regulatory submission packages - Prior experience supporting Department of Defense (DoD), federal health, or military research organizations - Familiarity with clinical data structures, including demographics, adverse events, laboratory, and longitudinal outcomes data Work Location: Primary support is associated with WRAIR in Silver Spring, MD. Remote work may be permitted, subject to task requirements and Government approval. Position Type: - Approximately 10-Month Period of Performance Pay and Benefits Pay for this position is $50.00 hourly.

Job Title: Clinical Research Nurse III Location: Philadelphia United States Job Description: Job Description This Clinical Research Nurse III role combines advanced clinical nursing practice with comprehensive coordination of oncology clinical trials. The position focuses on patient-facing care, subject recruitment and enrollment, consistent study implementation, meticulous data management, and strict adherence to regulatory and reporting requirements. The nurse supports cutting-edge research in a collaborative environment, working closely with experienced physicians and a multidisciplinary team while contributing to innovative therapies and improved patient outcomes. Responsibilities - Perform core clinical nursing duties in support of oncology clinical research studies, ensuring safe, compassionate, and evidence-based patient care. - Manage subject recruitment, including identifying potential participants, conducting screening procedures, and assessing eligibility according to study protocols. - Obtain informed consent from prospective participants, clearly explaining study objectives, procedures, risks, and benefits, and ensuring understanding before enrollment. - Support and oversee participant enrollment into clinical trials, coordinating all required baseline and follow-up assessments in accordance with protocol timelines. - Collect and document clinical information and research data from study participants accurately and consistently, using established data collection tools and systems. - Conduct detailed chart reviews to verify clinical information, confirm eligibility, and ensure data completeness and accuracy. - Monitor participants for adverse events, document findings thoroughly, and perform adverse event reporting in accordance with Good Clinical Practice (GCP), institutional policies, and regulatory requirements. - Provide patient education about research studies, including visit schedules, procedures, potential side effects, and adherence requirements, reinforcing information throughout the trial. - Coordinate day-to-day study operations to ensure consistent implementation of study protocols, including scheduling visits, tests, and procedures. - Maintain data integrity by entering, updating, and verifying information in electronic systems, including Epic and other research databases, and resolving discrepancies promptly. - Ensure compliance with regulatory requirements and reporting obligations, including adherence to GCP guidelines and institutional and sponsor policies. - Interact with consortium members and external partners, fostering effective communication and collaboration across participating institutions. - Organize and coordinate meetings with consortium and study team members, including scheduling, preparing agendas, and ensuring appropriate participation. - Track and record study progress, including enrollment metrics, participant status, and key milestones, and communicate updates to stakeholders. - Schedule study-related meetings, record detailed minutes, and distribute documentation to relevant parties to ensure clear communication and follow-up on action items. - Collaborate closely with the genitourinary (GU) research team, supporting their portfolio of studies and contributing to team-based problem-solving and process improvement. - Assist with or provide leadership in aspects of study management as needed, drawing on prior management experience to support junior staff and streamline workflows. - Contribute to a culture of continuous learning and professional development by engaging in training, staying current on research protocols, and sharing best practices with colleagues. Essential Skills - Active Registered Nurse (RN) license in the state of Pennsylvania (PA RN License). - Nursing Diploma or Associate's Degree in Nursing, with the ability to practice as a registered nurse. - Minimum of 2 years of overall professional experience as a registered nurse. - Minimum of 1 year of RN clinical experience providing direct patient care. - Minimum of 1 year of clinical research experience, preferably in a research center or similar setting. - Demonstrated experience in clinical research coordination, including patient recruitment, screening, and enrollment into clinical trials. - Proficiency in collecting and documenting clinical information and research data from study participants with high accuracy. - Experience conducting chart reviews to validate eligibility criteria and ensure data completeness. - Competence in adverse event identification, documentation, and reporting in accordance with regulatory and institutional requirements. - Working knowledge of oncology clinical care and oncology research workflows. - Familiarity with Good Clinical Practice (GCP) guidelines and their application in clinical research. - Ability to provide clear, empathetic patient education about research studies, including informed consent processes. - Proficiency with Epic or similar electronic medical record systems for clinical documentation and data retrieval. - Strong organizational and time-management skills, with the ability to manage multiple studies, tasks, and timelines concurrently. - Effective verbal and written communication skills to interact with patients, study teams, and consortium members. - Attention to detail and commitment to maintaining data integrity and regulatory compliance. Additional Skills & Qualifications - Bachelor of Science in Nursing (BSN) preferred. - Some prior management or supervisory experience preferred, particularly in a clinical or research environment. - Experience working within pharmaceutical-sponsored trials or industry-partnered research is beneficial. - Background in oncology research, especially in genitourinary (GU) oncology, is advantageous. - Experience working in a research center environment, including collaboration with multidisciplinary teams. - Strong interpersonal skills and the ability to build rapport with patients, families, and colleagues. - Demonstrated ability to participate in or facilitate meetings, including preparing agendas and recording minutes. - Interest in professional growth and ongoing development within clinical research and nursing practice. Work Environment This role operates in a mixed office and hospital-based environment, providing exposure to both direct patient care settings and administrative research functions. The nurse works closely with physicians and a multidisciplinary research team on cutting-edge clinical trials, particularly within oncology and genitourinary (GU) research. Daily work involves the use of Epic electronic medical records, research databases, and standard clinical and office equipment. After approximately 60 days of training, the position may offer the flexibility to work from home one to two days per week, depending on study needs and operational requirements, with the understanding that remote work frequency may fluctuate. The culture emphasizes professional growth, with opportunities for advancement, tuition reimbursement upon conversion, and access to low-cost health benefits. The environment values collaboration, continuous learning, and participation in innovative research that advances patient care. Job Type & Location This is a Contract to Hire position based out of Philadelphia, PA. Pay and Benefits The pay range for this position is $35.00 - $45.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Philadelphia,PA. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Clinical Research Assistant - CAIR and HPNP Location: Boston, MA United States Status Full-Time Standard Hours per Week 40 Job Category Research Regular, Temporary, Per Diem Regular Pay Range $41246.40-$61339.20 Annual Remote Eligibility Part Remote/Hybrid Job Description: Job Posting Description At Boston Children’s Hospital, the quality of our care – and our inclusive hospital working environment – lies in the diversity of our people. With patients from local communities and 160 countries around the world, we’re committed to reflecting the spectrum of their cultures, while opening doors of opportunity for our team. Here, different talents pursue common goals. Voices are heard and ideas are shared. Join us, and discover how your unique contributions can change lives. Yours included. Position Summary: The Center for Advanced Intestinal Rehabilitation and Home Parenteral Nutrition Program is seeking a Clinical Research Assistant to support day-to-day study operations, participant engagement, clinical data collection and management, and collaboration with our interdisciplinary gastroenterology and surgical research teams. The primary study evaluates whether a 4% Tetrasodium (EDTA) catheter lock solution is more effective than standard heparin lock therapy in preventing central venous catheter occlusions and bloodstream infections in children with intestinal failure and short bowel syndrome. The Center for Advanced Intestinal Rehabilitation and Home Parenteral Nutrition Program at BCH is the largest program of its kind and serves as a major site in this 52-week multi-center randomized controlled trial. Participants completing the initial study may also enroll in an extension study, which will additionally fall under this role’s responsibilities. This position will also support two additional industry-sponsored clinical trials: - A multicenter study evaluating DEFENCATH in reducing central-line associated bloodstream infections (CLABSIs) in adults receiving total parenteral nutrition through a central venous catheter. - A global Phase 3 trial assessing apraglutide in adults with short bowel syndrome-associated intestinal failure. Currently, our site has enrolled 27 subjects in the EDTA study, with overall enrollment across participating sites exceeding 75% of the planned recruitment goal. Prior experience with intestinal failure, short bowel syndrome, or parenteral nutrition is not required. This role offers the opportunity to directly contribute to advancing therapies and improving outcomes for pediatric and adult patients with intestinal failure and short bowel syndrome. This position will also have opportunities to participate in additional clinical research studies and projects as they arise within the program. Key Responsibilities: - Consents and recruits patients for research studies through personal interviews and written communications with patients/families. Provides detailed background information regarding studies to families, communicates all policies and procedures, and responds to all inquiries. Evaluates suitability of prospective study candidates and makes selections based upon clinical knowledge of each study - Serves as liaison to the families/patients in the research studies, conducted at both on site and off site locations, guiding and advising them throughout each phase of the study. Coordinates follow up visits as necessary. Acts as a resource to study participants, addressing any concerns they may have. Troubleshoots resolution of any issues that may arise throughout the study - Coordinates and prepares the necessary documentation for Institutional Review Board IRB and Committee on Clinical Investigations CCI submissions, together with the Private Investigator of the study - Creates and prepares data collection statistical reports and analytical summaries for distribution to study research team for review and analysis. Writes articles and summary papers of studies for submission to medical journals, as may be necessary/requested - Participates in the training of newly hired research study assistants, as required - Coordinates activities between the hospital and research laboratories to ensure correct testing/processing and send out instructions specific to the study. Communicates project policies and procedures to personnel. Monitors and reviews data collection and data entry, and informed consent procedures ensuring consistency of application for each study Minimum Qualifications Education: • A Bachelor’s Degree in STEM, Psychology or a related field is required Experience: - GI or surgery experience is preferred - Ability to make a 2 year commitment is strongly preferred The posted pay range is Boston Children’s reasonable and good-faith expectation for this pay at the time of posting. Any base pay offer provided depends on skills, experience, education, certifications, and a variety of other job-related factors. Base pay is one part of a comprehensive benefits package that includes flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork. Boston Children’s Hospital is an Equal Opportunity / Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, sexual orientation, gender identity, protected veteran status or disability.