Principal Biostatistician RWE (NA Only) - with PASS (Post Authorization Safety Surveillance) Experience

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

*Must be located in US or Canada with no sponsorship needs to be considered for this remote role.

*Previous industry experience leading RWD studies is required.

•Serves as a statistical department resource, mentors biostatisticians on job skills, oversees or develop training plans or materials for Biostatistics associates. Conducts training sessions, or otherwise trains new hires and enhance the skills of existing personnel.

•Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor, if required.

•Responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.

•Reviews SAS annotated case report forms (CRFs), SAS 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.

•Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.

•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 statisticians in the department.

Experience with:

• RCT
• CT
• RWD

RWD experience, including but not limited to:

• eMR
• Claims and Billing Data
• Patient registries
• Patient-Generated Data
• Pharmacy Data
• Device/Wearables

General Statistics

• TTE
• Mixed Methods
• Regression
• Subgroup analyses
• Sensitivity Analysis
• Missing data methods
• ML
• Predictive Modeling
• Meta-analysis
• Neural network analysis
• Cluster analysis

RWE analysis experience, including by not limited to:

• Comparative Effectiveness Research
• Exploratory Data Analysis including descriptive statistics
• Propensity Score Matching
• Causal Inference
• Health Economics and Outcome Research (HEOR)
• Country specific Dossiers
• Risk modeling
• Signal detection
• Biomarker trends
• Interrupted Time Series Analysis
• Network Meta-Analyses using RWD

Specifics of the position

• Fast growing
• HEOR, HTA, cost effectiveness
• R will be important – matchit, mice (multiple imputation)
• SQL
• Clarity and HealthVarity data (Claims and eMR record merged
  • • Primarily for marketing group
    • Treatment patterns
• Goal is to execute as well as guide the client
• Free government data
  • A lot of pre-processing
• Evaluation of data quality
• Feasibility check for different databases
• Sample size calculations

•Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies.

•Proficiency in programming.

•Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.

•Experience with regulatory submissions preferred. Excellent written and verbal communication skills.

•Ability to read, write, speak, and understand English.

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.

Salary Range:

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.

Get to know Syneos Health

Over 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.

http://www.syneoshealth.com

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.