Statistical Programmer I at BIOTRONIK, Inc. in Lake Oswego, Oregon

Job Description:

Statistical Programmer I

BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees. 

BIOTRONIK is looking to add a Statistical Programmer I to our Clinical Data Operations team.  The Statistical Programming group is responsible for providing statistical support and data management services for our clinical trials.  The Statistical Programmer I will be responsible for statistical analysis of clinical research data and development of standardized data processing applications necessary for analysis, reporting, and operational management of studies.  

 

Your Responsibilities

• Consult on protocol design and statistical analysis plan for clinical studies


• Support clinical database development, testing, validation, and maintenance 


• Support electronic Case Report Form development (eCRF) and collaborate with Clinical Programmer to implement coding standards


• Clinical database development, testing, validation, and improvement, as required.


• Perform statistical analysis of clinical trial data to support reporting for regulatory submissions and publications


• Support adhoc analysis request and provide input on database design/structure


• Support statistical methods to develop and maintain a Real World Evidence strategy to support products from clinical development through licensing, market access, and lifecycle management with complex healthcare data (Claims, EMR, and Registry data).
  
  
  
  • Develop understanding of Real World Evidence needs at the functional level and contribute to a plan of action to utilizing existing medical device evidence or conduct retrospective and prospective research protocols to best address targeted research questions.
  
  
  • Support post-marketing activities including participate in design of post-marketing safety and effectiveness studies/registries.
  
  
  • Contribute to the development of SOPs, guidelines, and templates to support conduct of Real World Evidence studies.
  
  
  
  


• Support execution of plans to build, implement and maintain predictive models using available tools and programming languages to predict complication risks, medical device outcome performance, etc. Support the monitoring and feedback on model performance and support re-calibration of the model as necessary. 


• Participate in FDA and/or industry meetings on clinical data analysis initiatives as requested


• Ensure deadlines for deliverables are met in coordination with project team 


• Ensure documentation of critical implementation decisions made during development 


• Perform other duties upon request

Your Profile

• Master’s degree in Applied Statistics or Biostatistics, or equivalent experience


• Up to 2 years of experience managing clinical data in pharmaceutical, biotech, or medical device industry 


• Expertise in development of relational databases, SAS code, SQL, MS Access 


• Knowledge of clinical research, ICH-GCP, GCDMP, FDA and related regulatory requirements.  


• Excellent verbal and written communication skills


• Demonstrated problem solving skills


• Formal training in biostatistics and ability to apply statistical analysis concepts to clinical research data


• Knowledge of current GCP/ICH guidelines and FDA guidelines pertinent to software development in a regulated environment


• Experience with advanced programming and data analysis using SAS


• Knowledge of clinical research process and clinical data management


• Strong communication skills (verbal and written) to express complex ideas


• Excellent organizational and interpersonal skills


• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities


• Ability to manage multiple priorities within a variety of complex clinical trials


• Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical study settings

Travel Requirements

• Minimal travel expectations but must have willingness and ability to travel domestically and internationally as required


• If home-based employee, travel to the Lake Oswego office periodically, as required by management for BIOTRONIK, department, or project required-training and/or face-to-face meetings.

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

Location: Lake Oswego, OR | Working hours: Full-time  | Type of contract: Undefined 

Apply now under: www.biotronik.com/careers

Job ID: 39751  | Contact: Amanda Willott 

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.