Principal Biostatistician RWE (NA Only) - with PASS (Post Authorization Safety Surveillance) Experience
About The Position
Syneos Health is a leading life sciences services organization focused on accelerating customer success by partnering with innovators across the drug development and commercialization continuum. The Clinical Solutions team members operate with a drug development mindset, leveraging their expertise to understand and address customer needs. This role involves collaborating with passionate problem solvers to achieve customer goals, emphasizing agility and a commitment to delivery for colleagues, customers, and patients. The company is dedicated to people development through career progression, supportive management, training, and recognition. They are committed to building an inclusive culture where individuals can be authentic, driven by a purpose to deliver solutions that significantly impact lives. Syneos Health aims to be a company that employees want to work for and customers want to work with, believing that diverse teams can shape the future of healthcare and advance patient progress.
Requirements
- 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.
- 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.
- Ability to read, write, speak, and understand English.
Nice To Haves
- Experience with regulatory submissions preferred.
- 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
Responsibilities
- 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.
Benefits
- 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
- flexible paid time off (PTO) and sick time
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
No Education Listed
