Syneos Health

Project Manager

• Manage intake, tracking, and ongoing oversight of locally sponsored studies across the HIV treatment and prevention portfolio
• Monitor study milestones, timelines, deliverables, and key performance indicators to ensure visibility and proactive management of study progress
• Identify studies that may be at risk for delays, escalation, or closure and communicate findings to appropriate stakeholders
• Support internal and external protocol review board processes (iPRB/oPRB), including submission coordination, documentation management, tracking, and comment adjudication activities
• Maintain portfolio tracking tools, dashboards, and reporting systems to ensure accurate and timely visibility into study status
• Track publication plans, including abstracts, posters, presentations, and manuscripts across the portfolio
• Develop forecasting reports and publication timelines to support strategic planning activities
• Generate recurring portfolio metrics, study summaries, and status reports for Medical Affairs leadership and key stakeholders
• Assist in the development of executive-level presentations and slide decks supporting Medical Affairs Research (MAR) initiatives and portfolio narratives
• Ensure consistency, completeness, and accuracy across study documentation, tracking systems, and internal reporting tools
• Facilitate communication across study teams and stakeholders to ensure alignment on deliverables, timelines, and expectations
• Support process improvement initiatives that enhance portfolio management, reporting efficiency, and study oversight capabilities
• Maintain awareness of portfolio priorities and proactively identify opportunities to improve visibility, efficiency, and execution

Project Manager II – HIV Research, Portfolio Management Support

Software Engineer

• Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
• Works to ensure that outputs meet quality standards and project requirements.
• Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
• Keeps project team members informed of programming progress and issues requiring their attention.
• Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
• Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
• Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
• Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus.
• Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
• Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted.
• Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables.
• Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.
• Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.
• Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.
• Transfers deliverables.
• Performs other work-related duties as assigned.

Principal Statistical Programmer

Clinical Operations

• Drive operational execution of Early Phase Oncology clinical trials from study start-up through database lock and closeout
• Independently manage day-to-day study operations with minimal oversight
• Own timelines, deliverables, risks, and issue resolution across multiple workstreams
• Maintain deep operational awareness across all aspects of the trial — this is a role for someone comfortable working "in the weeds"
• Ensure study milestones stay on track in a fast-paced environment with shifting priorities and competing demands
• Partner cross-functionally to proactively identify risks, remove roadblocks, and implement operational solutions quickly
• Support operational activities associated with dose escalation cohorts, dose expansion cohorts, safety review meetings, protocol amendments, enrollment management, and study execution activities
• Monitor enrollment, site performance, data quality, and operational metrics to support successful study execution
• Drive accountability across study teams to ensure timelines and deliverables are met
• Lead vendor management activities and maintain strong oversight of external partners and CROs
• Contribute to RFP development, vendor selection, and ongoing vendor performance management
• Hold vendors accountable to timelines, deliverables, quality expectations, and issue resolution
• Actively manage operational follow-through rather than relying solely on escalation pathways
• Partner closely with CROs, monitoring teams, central laboratories, imaging vendors, and specialty oncology service providers
• Lead cross-functional meetings with clear agendas, action-oriented discussions, and strong follow-up
• Drive accountability across internal teams and external partners
• Build strong collaborative relationships while effectively navigating challenging conversations and competing priorities
• Mentor or support junior team members as needed
• Operate confidently within a matrixed global environment with multiple stakeholders
• Draft, review, and coordinate key study documents including protocols, informed consents, monitoring plans, investigator brochures, clinical study reports, and other essential study documentation
• Support study budget tracking, forecasting, and operational planning activities
• Review data listings and support interim and final reporting activities
• Train CROs, investigators, study coordinators, and vendors on protocol and study requirements
• Support inspection readiness activities and maintain compliance with GCP, ICH, and applicable regulatory requirements
• Contribute to SOP development, process improvement initiatives, and operational best practices

Clinical Project Manager II – Early Phase Oncology

Medical writer

• Writes, edits, and coordinates content for clinical/regulatory documents
• Leads the clear and accurate completion of medical writing deliverables
• Manages medical writing activities associated with individual studies
• Completes a variety of documents that may include clinical study protocols, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, and more
• Leads the resolution of comments from the client
• Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format
• Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs
• May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities
• Mentors and leads less experienced medical writers on complex projects

Medical Writer II – Senior Medical Writer

Data Scientist

• Collaborate with passionate problem solvers, innovating as a team to help customers achieve their goals
• Assess quality of the data
• Conduct analyses (programming of TFLs)
• Review and input Protocol and SAP
• Conduct longitudinal cohort studies and create study cohorts from scratch

Senior Data Scientist - Real-World Data (SAS, R)

• Act as a sponsor-facing project manager, ensuring the successful execution of assigned CAR-T and gene therapy trials from startup through closeout.
• Lead or support study start-up, site activation, and enrollment, working closely with site monitors, regulatory teams, and contracts personnel.
• Serve as a key point of contact across internal (CRO) and sponsor teams, facilitating regular communications, status reporting, and governance updates.
• Coordinate with cross-functional stakeholders to ensure timelines, budgets, and milestones are met, particularly in complex, high-touch studies.
• Track and manage protocol compliance, CAPAs, and site-level quality indicators; support resolution of audit findings.
• Ensure inspection readiness and regulatory compliance by overseeing TMF maintenance, data accuracy, and documentation completeness.
• Manage or contribute to the tracking of low-stability endpoint samples and IP-related processes, ensuring timely lab delivery and site support.
• Assist with risk identification and mitigation planning, while continuously optimizing trial execution processes.

Project Manager I – Cell & Gene Therapy

• Lead the design, development, configuration, and lifecycle management of RTSM/IRT/eCOA systems
• Partner closely with Clinical Operations and study teams to understand protocol requirements and ensure alignment on timelines, scope, and deliverables
• Develop and maintain User Requirement Specifications (URS) and system design documentation
• Serve as the primary operational point of contact for RTSM activities across assigned studies
• Provide ongoing RTSM/eCOA expertise throughout the entire study lifecycle
• Lead User Acceptance Testing (UAT) activities and validation efforts
• Ensure completion, review, and filing of testing and validation documentation
• Oversee quality reviews and approval of validation documentation
• Collaborate with vendors and study teams to identify, investigate, and resolve system issues
• Manage emergency changes and change control activities
• Act as the liaison between Clinical Operations, RTSM/eCOA vendors, and internal stakeholders
• Drive accountability for vendor deliverables and timelines
• Facilitate effective communication across matrixed teams
• Support issue escalation and resolution activities
• Ensure RTSM processes align with SOPs, regulatory requirements, and quality standards
• Support inspection readiness initiatives
• Identify process gaps and implement continuous improvement opportunities
• Develop standardized RTSM workflows and supporting guidance documents
• Ensure consistent execution across studies
• Manage RTSM user access requests, modifications, and removals
• Oversee periodic access reviews and audit readiness activities
• Develop and maintain role-based RTSM training materials
• Ensure training aligns with system functionality and regulatory expectations

eCOA Project Manager

Medical Director

• Provides medical oversight of assigned clinical studies in the duty as a medical monitor
• Often serves as primary medical contact for customers for assigned clinical studies
• Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department
• Responsible for protocol design and development, upon request
• Provides input into protocol amendments
• Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed
• Provides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts
• Provides medical input into data collection tools, monitoring plans, and review and analysis plans
• Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data
• Presents identified trends and issues, and mitigation strategies, to customers and project team members to minimize risks to subject safety or integrity of study data
• Provides after-hours medical coverage for clinical studies
• Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans
• Adheres to customer policies and standard operating procedures, as required in project plans
• Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines
• May support responses to Requests for Proposals (RFPs) or Bid Defense Meetings (BDMs), upon request
• May provide input to clinical development or regulatory teams within the Company, upon request
• May represent the Company at scientific meetings, upon request

Medical Director – HIV Research, Clinical/Observational Research

Clinical Research

• Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required.
• May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report.
• Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.
• Implements company objectives, and create alternative solutions to address business and operational challenges.
• Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
• Monitors progress on study activities against agreed upon milestones and ensures the study

Senior Biostatistician – Therapeutic Areas, Oncology, Vaccines

• Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates.
• Conducts training sessions, or otherwise trains new hires and enhance the skills of existing personnel.
• Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work.
• Provides independent review of project work produced by other biostatisticians in the department.
• Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor, if required.
• May be responsible as Lead Biostatician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
• Implements company objectives, and creates alternative solutions to address business and operational challenges.
• As biostatistics representative on project teams, interfaces with other departmental project team representatives.
• Preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.

Principal Biostatistician – Therapeutic Areas, Oncology / Vaccines

Data Analyst

• Contribute to the design of RWE studies, including protocol development, statistical analysis plans (SAPs), and other key study documents with moderate supervision.
• Apply working knowledge of real-world data sources (e.g., claims, EMR/EHR, registries, omics data, wearable data, PROs) to inform study design, feasibility assessments, and methodological decisions.
• Strong fluency in at least one of SAS or R is mandatory.
• Perform statistical analyses using SAS, R, Python, SQL, and other appropriate tools, ensuring data quality, reproducibility, traceability, and methodological rigor.
• Develop operational definitions, code lists, and analytical specifications aligned with study objectives and industry standards.
• Prepare high-quality tables, figures, and listings (TFLs) and contribute to study reports, manuscripts, and client deliverables with clear interpretation of findings and articulation of limitations.
• Support client-facing support, including presenting planning and project updates, explaining methodologies, addressing technical questions, and contributing to strategic discussions.
• Demonstrate a consulting-oriented approach by identifying risks, proposing solutions, and adapting to evolving client needs.
• Support management of assigned programming timelines and analytical workstreams across multiple concurrent projects; communicate progress, risks, and mitigation strategies effectively to internal and external stakeholders.
• Support proposal development, desk research, and exploratory analyses as needed.

Data Analyst II, RWE

Manager

• Collaborates with major functional areas including Business Development and Project Management
• Ensures project deliverables meet internal and customer expectations
• Provides oversight of site selection and activation processes
• Develops and maintains customer relationships

Site Activation Manager I/II

Proposal Manager

• Receives and analyzes Requests for Proposals (RFPs) from Business Development (BD) and ensures appropriate Subject Matter Experts (SMEs) are assigned to and notified of the RFP.
• Prepares and modifies proposal text, budgets, and cover letters responding to requests for proposals (RFPs) and rebids based on feedback received from SMEs, without assistance from proposal management staff except for the most complex RFPs or situations.
• Ensures proposal text and budgets are in agreement with RFP, client specifications and communications, and internal assumptions.
• Obtains third party quotes as needed.
• Manages the proposals process from RFP receipt to proposal delivery, identifying potential barriers or risks for completion and identifying and implementing mitigation strategies. Escalates to management when deliverables are at risk based on process stage gates.
• Works with contracts, finance, and operations to facilitate project initiation as part of PlanActivation™.
• Updates proposals and/or sales management tools, systems and/or forms regarding proposal or rebid status and value as directed.
• Coordinates and participates in project hand-over meetings.
• Present budgets in client-specific/requested formats.
• Provides functional guidance and application of process guidelines to internal constituents as needed.
• May perform peer QC prior to manager sign-off according to departmental procedures and guidelines.
• Suggests and implements pricing and proposal strategies to improve quality of proposal. Collaborates with team members, operations and business development, to customize and develop proposal submissions.

Analyst

• Provides assistance on organizational projects and initiatives which may include: Training System deployments and/or enhancements Process development and documentation Validation activities which may include testing Assisting with data migrations
• Participates in process improvements which may include: Assisting in the redesign and improvement of business
• Assist in problem identification and resolution which may include: Monitoring operational indicators to identify and escalate critical business issues Exercising appropriate critical thinking/problem solving skills to identify and understand a problem, analyze and communicate impact, and bring to timely resolution
• Provides accurate operational metrics for areas overseen by Global Operations Management which may include: Extracting data from systems or applications Analyzing metrics and identify exceptions, erroneous data, gaps, trends, and improvement opportunities Communicating metric findings as necessary
• Support end Users of process and system(s) which may include: Responding to end user questions or requests by providing guidance and or resolution Identifying issues for escalation routing appropriately (to other team members, internal resources, external resources, etc.) Documenting support issues to ensure issues/requests are resolved
• May assist with preparation and maintenance of end-user training materials and job aids

Bus Process and Performance Analyst

• Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
• May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report.
• Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work.
• Provides independent review of project work produced by other biostatisticians in the department.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.
• Implements company objectives, and create alternative solutions to address business and operational challenges.
• Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
• Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met.
• Identifies out of scope tasks and escalate to management.
• Provides statistical programming support as needed.
• May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician.
• May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
• Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.
• Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
• Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Coaches and mentors other Biostatistics staff.
• Performs other work-related duties as assigned.
• Minimal travel may be required.