RWE Methodology Sr Director

RWE Methodology Sr Director

JOB SUMMARY

The Senior Director, Real World Evidence Methodology, RWE will provide strategic methodological guidance on Sponsor’s Real World programs including development of real world evidence plans, working with epidemiology team members to select optimal study designs, determining study feasibility, and advising on advanced scientific and statistical methods for study execution. This role will serve as a RWE scientific expert offering organizational infrastructure and business development support to Syneos Health RW and Late Phase (RWLP).

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.  

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.

Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 
• 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

·    Partner with clients to identify their RWE needs, create RWE strategic plans, and collaborate with RWLP epidemiology team to design studies to fill evidence gaps

·       Serve as scientific and statistical methodology SME for RWLP epidemiology and analytic teams in the area of RWE generation

·       Clearly and succinctly communicate RWE methodological strategies, risks, mitigations, contingencies and potential outcomes to the client

·       Provide strategic methodologic direction on RWE generation programs including support of regulatory / Health Authority interactions

·       Maintain familiarity with relevant industry guidance and regulatory regulations for real world research study designs, research trends and state of the art analysis methodologies

·       Act as a SME in RWE generation across Syneos Health developing innovative Real World Data (RWD)-based solutions 

·       Provide expert guidance on database resource selection and feasibility assessment

·       Direct analyses for a wide variety of real world data resources and purposes contributing to the development of study protocols and analysis plans

·       Build relationships/partnerships with external experts/consultants/advisors/thought-leaders

·       Work hand-in-hand with RWLP management, business development, and operations personnel to develop and win global business opportunities; helps to lead the development and delivery of project proposals, bid defenses, and represents capabilities presentations.

·       Enhance growth, identify opportunities, and contribute to the development and upkeep of sales enablement collateral

·       Develop abstracts, podium presentations, and authorship of articles, manuscripts, etc. in industry and peer-reviewed journals to promote Company services in alignment with sales and marketing strategy.

·       Responsible for the continued building of organizational capacity, improvement of scientific and operational processes and methodologies, integrated RWLP technology solutions including secondary database resources, analytic methods, and RWLP Standard Operating Procedures (SOP) development and maintenance.

·       May travel up to 25% of the time. 

·       Lead or actively participate in departmental, project, leadership, and other initiatives. 

·       Provide training and mentoring for internal team members

·       Work collaboratively across the Syneos Health organization to promote RWE

 QUALIFICATION REQUIREMENTS

·Graduate degree in Epidemiology, Economics or Statistics (MS/MPH plus industry specific experience; PhD Preferred) with experience in the development of scientific studies and data analysis.

·Prior experience in the Biopharma, or CRO industry with extensive experience conducting real world research, post-marketing and late phase study designs as well as knowledge of relevant industry and regulatory guidelines.

·Must possess strong methodologic background across various RW study designs and the ability to develop and implement complex global real world evidence strategies. 

·Proven ability to provide expert consultation on RWE strategy, study design and analytic methods to project teams, Sponsors, and Regulators/Health Authorities. 

·Demonstrated strategic thinking skills, sound judgement, and ability to integrate strategies into actionable plans.

·Knowledge of US and Global sources, their fitness for different uses, and basic understanding of statistical programming language required (e.g., SAS, R, Python).

·Strong team player: the ability to work flexibly in a collaborative environment and guide team members as needed to achieve goals.

·Able to work independently on competing priorities in a fast-paced and dynamic environment.

·Must be comfortable in a customer-facing role while also able to provide detailed technical and methodological expertise. 

·A comprehensive grasp of the drug development process, particularly in the context of RWLP study designs, along with a working knowledge of the essential activities across all key functional areas. 

·Excellent oral and written communication and presentation skills; ability to communicate complex issues clearly and concisely. 

·Exceptional attention to detail, accuracy, documentation and organization.

Get to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. 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.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance.  The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.  Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

The annual base salary for this position ranges from $145,170 to $306,500 USD.  The base salary range represents the anticipated low and high of the Syneos Health range for this position.  Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.