Syneos Health

Updated: May 9, 2024 Location: London, ENG, United Kingdom Job ID: 4228 You are organised, driven, and thrive in an ownership position. Role Overview The primary purpose of this role is to work alongside the account teams in being accountable for meeting the business objectives of the clients both strategically and financially. As well as using experience to develop innovative tactical and strategic plans that are well aligned to client needs. Responsibilities Takes final responsibility for the overall output from their group Takes responsibility for issues management, internally and externally Sets the example for professionalism & work ethic for their group Through active mentoring/performance management shows evidence of progressing individuals, especially, to the PMW level by teaching technical and non-technical skills Involved in development of new business, both directly, through pitching, and indirectly by providing scientific background and strategy. Is the voice of calm and reason, the 'port in the storm' for their colleagues and clients Must have extensive Medical Writing experience gained within a Healthcare Agency setting Apply sound business insight & judgment in the best interests of the agency & our clients Has an expert level of understanding of med comms and the overall healthcare industry and shares their point of view internally and externally Has a track record of identifying potential issues before they arise and pro-actively managing them At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities. Litmus Medical Communications acts as a catalyst to accelerate uptake and embed the value of therapies across the product lifecycle, bringing business strategy to science and scientific expertise to your business. With our base in Europe, we are cognizant of the diverse healthcare systems, regulations and market dynamics of the region; however, we are not limited by geography and support our customers at a local, European and global level. Whatever the reach required, we specialise in building relationships, understanding and collaboration between the biopharmaceutical industry and medical/healthcare professionals. We develop a range of strategic solutions based on an understanding of both the objectives and issues of our customers as well as their stakeholders, focusing on facilitating peer-to-peer and scientific communications through a range of channels. As effective and compelling communication is key, whether for a marketing story, scientific data or market access support, we have a dedicated editorial excellence team providing content that can be syndicated to deliver solutions to enhance patient care. W o r k H e r e M a t t e r s E v e r y w h e r e How are you inspired to change lives? Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled) Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients' lives around the world. Selecting us as an employer secures a career inwhich you're guaranteed to: Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.To learn more about how we are Shortening the distance from lab to life, visit . Phone: Fax: Toll-Free: Syneos Health is an Equal Opportunity Employer. All qualified applicants will receiveconsideration for employment without regard to race, color, age, religion, marital status,ethnicity, national origin, sex, gender, gender identity, sexual orientation, protectedveteran status, disability or any other legally protected status and will not bediscriminated against. If you are an individual with a disability who requires reasonableaccommodation to complete any part of our application process, including the use of thiswebsite, please contact us at: Email: email protected . One of our staff members willwork with you to provide alternate means to submit your application.

Manager, Biostatistics - FSP team Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why Syneos Health • means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job responsibilities • Ensures that the Biostatistics department meets timelines, provides high quality deliverables, complies with contractual project requirements and Standard Operating Procedures (SOPs), and conducts projects within budget. • May participate in the development of department SOPs and guidelines, promoting standardized and consistent processes to maximize the efficiency of the Biostatistical department. • Responsible for staff development, training and retention. Oversees development of direct reports by setting goals, managing performance, evaluating and monitoring training needs, supporting development plans, mentoring, and coaching. • Facilitates succession planning and maintains a Biostatistics staff with diverse skills, abilities, and competencies to meet the business needs of the Biostatistics department. • Makes recommendations for, and participates actively in hiring, onboarding, transferring, and terminating staff. • Maintains a good working knowledge of clinical drug development, ICH, and other regulatory guidelines, and biostatistics in order to effectively serve as a Biostatistics department mentor. Develops and provides training for Biostatistics associates. • Prioritizes activities across Biostatistics projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals, creating solutions to address business and operational challenges. • Supports the assignment of, or directly assigns Biostatisticians to projects in a manner which keeps associates at their utilization goal and which matches associates to projects appropriate to their skills, training and experience. • May conduct senior review of project deliverables, ensuring that output meets expectations and is consistent with analysis described in study documents. • May be responsible for leading or participating in projects across multiple studies or programs. • May support business development activities. • May participate in, or lead departmental or corporate initiatives. • Performs other work-related duties as assigned. • Minimal travel may be required. What we're looking for • Graduate degree, or equivalent, in biostatistics or related discipline. • Extensive experience in clinical trials or equivalent combination of education and experience with increasing levels of responsibility. • Previous management experience or demonstrated leadership ability preferred. • Extensive knowledge of the drug development process, regulatory requirements and relevant guidelines. • Experience with regulatory submissions preferred. • Ability to read, write, speak, and understand English. • Excellent communication, presentation and interpersonal skills, with an ability to inform, influence, convince, and persuade. Get to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

JOB SUMMARY This position is responsible for leading projects across multiple studies or programs. A Senior Biostatistician acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects. JOB RESPONSIBILITIES 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 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. QUALIFICATION REQUIREMENTS Graduate degree in biostatistics or related discipline. Moderate experience in clinical trials or an equivalent combination of education and experience. Proficiency in programming. Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts. Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR. Excellent written and verbal communication skills. Ability to read, write, speak, and understand English. "Syneos Health is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability."

Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 24,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients' lives around the world. Summary: As an Executive Director of Clinical Development focusing on the General Medicine therapeutic area, you will oversee business aspects of clinical operations, project management and business development assistance for the General Medicine Business Unit to achieve target revenue and profitability while ensuring the contracted services and expectations of all projects are carried out by the project teams in accordance with executed contracts and Customers' expectations. Duties include management of staff utilization and realization of project revenue for business unit (BU), analysis of financial data, assuming role of primary liaison with Customers, Vendors, Senior Management and Investigator sites as needed, and organizing department hierarchy and processes to achieve targets. May include line management responsibilities for project management and clinical staff within BU. Essential Functions: 1. Provides oversight for all assigned BU projects to ensure study launch, conduct and closeout occurs according to the Customer's and company's contractual agreement. Ensures studies progress according to internal and Customer quality standards, SOPs, GCPs and ICH guidelines to fulfill all federal and local regulations. 2. Forecast, prioritize and direct staff to achieve on-time quality sponsor deliverables, contractual project requirements, utilization goals and profitable results. 3. Works with senior management and Business Development to set strategic direction for BU to better target types of projects across selected customer segments, makes recommendations, and drives strategy execution for successful business growth. 4. Evaluates progress of BU projects and assigned staff to ensure the meeting of targets for utilization, realization, and timelines. 5. Actively manages and mentors Project Management staff in leadership skills, customer management skills, project management skills, Trusted Process compliance, and for project specific tasks. Ensures appropriate training and development is provided to all assigned staff. 6. As necessary, troubleshoots difficulties which may arise in project conduct between the company and Customer, and/or between Clinical Development. Facilitates team building and communication. Acts as a liaison and facilitator between other functional areas for overall operational issues. 7. Develops and maintains knowledge of current therapeutic/critical market environment and drug development trends as needed. Facilitates team training in accordance with protocol and/or project requirements. Other Responsibilities: Performs other work-related duties as assigned.Requirements: Requires a BA/BS in the life sciences, nursing degree, or equivalent education or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical, or biotechnology company. Must have spent some time actively managing clinical research projects across functional areas, and other relevant experience is advantageous. Previous supervisory experience and pharma/CRO experience is required. Thorough knowledge of FDA regulations, drug development, and clinical monitoring procedures is necessary. Must have demonstrated proficiency with ICH/GCP guidelines. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail is required. Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment is essential. Requires strong presentation, documentation and interpersonal skills as well as a team-oriented approach. Must have valid, current driver's license and ability to secure corporate credit card. Disclaimer: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. #LI-JH1

*Senior Project Manager* Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. *Why Syneos Health* • #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. *Job responsibilities* Project Leadership and Delivery: • Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements. • Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer's and the Company's contractual agreement. • Leads clinical team to ensure quality, timelines and budget management. • Accountable for the financial performance of assigned projects • Accountable for all project deliverables for assigned projects and/or project regions. • Coordinates activities and deliverables of all project conduct partners and proactively identifies and manages issues. Reporting and Communication: • Accountable for maintenance of project information on a variety of databases and systems. • Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. • Responsible for project management components of inspection readiness for all aspects of the project conduct, including Trial Master Files. • Provides oversight for development and implementation of project plans in accordance with Controlled Documents. • Independently prepares, coordinates, and presents project material at internal and external meetings. • Directs the activities of assigned Project Support staff; line manages and mentors other project management team members and clinical staff; facilitates team building and communication. • Prepares project management reports for clients and management. • Implements resource strategies to achieve project goals. • Develops contingency planning and risk mitigation strategies to ensure successful delivery of project goals. Business Development • Participates in bid defense meetings where presented as potential project manager/director. • Develops strong relationships with current clients to generate new and/or add-on business for the future. • Keeps a current awareness of business unit's and assigned projects' therapeutic environment and drug development trends Management: • May train and support new Project Managers. Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training. • May be required to line manage other project management team members and clinical monitoring staff*What we're looking for* • Bachelor's Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience. • Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and clinical monitoring procedures. • Clinical research organization (CRO) and relevant therapeutic experience preferred. • Strong ability to manage time and work independently. • Ability to embrace new technologies. • Excellent communication, presentation, interpersonal skills, both written and spoken • Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment. • Ability to travel as necessary (approximately 25%). *Get to know Syneos Health* We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. *Additional Information:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. #LI-LT1