Principal Biostatistician (RWE Specialist - NA and Europe)

Reposted Yesterday
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6 Locations
In-Office or Remote
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
The Principal Biostatistician will lead RWE projects, access and analyze real-world data, ensure data quality, and develop analytical tools, collaborating with cross-functional teams.
Summary Generated by Built In
Principal Biostatistician (RWE Specialist - NA and Europe)

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.  

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

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

  • Must be located in NA or Europe. If in NA must be open to working EST hours.
  • Previous lead industry experience within RWE/RWD is required.
  • Understand and be familiar with licensed RWD database;
  • Independently identify, access, and assess in-house real-world data sources (EHRs, claims, registries, etc.) relevant to clinical trial populations and endpoints
  • Access and summarize non-patient-level real-world data (publications, aggregate claims or EHR analytics, federated learnings, external collaborations, etc.) relevant to clinical trial populations and endpoints
  • Critically evaluate data quality, completeness, and suitability for specific trial design questions
  • Develop RWD exploration plans
  • Clean, process, and harmonize raw RWD for analysis, applying data governance and privacy standards
  • Use SAS, R, Python and/or other advanced analytical programming tools to perform statistical analyses and generate insights on patient characteristics, treatment patterns, outcomes, and epidemiology
  • Prepare clear, concise evidence summaries and visual reports to inform protocol development (inclusion/exclusion criteria, endpoints, comparator selection, feasibility assessments, etc.)
  • Collaborate cross-functionally with clinical, regulatory, biostatistics, and medical teams
  • Stay current on RWD methodologies, regulatory guidance, and technological advances in the field
  • Ensure all work supports timely, high-quality decision making for new clinical trial design and execution
  • Develop new innovative RWD analytical tools where needed

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.

Top Skills

Claims
Ehrs
Python
R
Registries
SAS
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The Company
HQ: Morrisville, NC
22,543 Employees

What We Do

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.

We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics.
Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.

Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.

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