Principal Biostatistician RWE (NA Only) - with PASS (Post Authorization Safety Surveillance) Experience
Principal Biostatistician RWE (NA Only) - with PASS (Post Authorization Safety Surveillance) Experience
- 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
Requirements:
- 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: $80,600.00 - $175,700.00 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. 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. Apply To This Job