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Senior Statistical Programmer

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Date: Jan 10, 2021

Location: US

Company: Cytel Inc

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services.  At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

 

As member of the Real World and Advanced Analytics department the Senior Statistical Programmer has knowledge and experience of working with Real World Evidence (EHRs, Claims/Payer data etc) and is able to employ newly evolving methodologies as well as current practice. The RWA group has a wide remit of evidence framing, knowledge of data assets, registries, pragmatic trials, external control arms that experience in one of these areas would be of benefit.

Delivers the programming aspets of RWA from development of analytical datasets, analysis of efficacy and safety endpoints plus exploratory analysis

 

Typical Accountabilities:

  • Data submission strategy (e.g., managing legacy data, pooling data) 
  • Responses to regulatory agency queries
  • Tables Figures and Listings (TFLs)
  • Development Safety Update Reports (DSURs)
  • Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Investigators brochures (IBs)
  • Office of Scientific Investigations (OSI) data sets and listings
  • Regulatory and/or Payer submission related analysis data sets and/or TFLs
  • Associated quality and process documentation as per applicable business processes
  • Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data sets
  • Pharmacokinetics/pharmacodynamics data preparation and analysis
  • Manipulating and analyzing adjudicated data
  • Data preparation and analysis for Global Medical Affairs work
  • Clinical Trial Transparency deliverables (data de-identification, results posting files)
  • Timely upload of documents to eTMF
  • Produce and maintain the technical database standards and Programming Specification documents.
  • Contributes to and/or lead aspects of the provision of technical consulting expertise to external partners in relation to the specifications and delivery of the appropriate data model  databases (eg. OMOP, SDTM )by these partners.
  • Contributes to and/or lead the development of best practice to improve quality, efficiency and effectiveness.
  • Identifies opportunities to improve the methodology and provide practical solutions for problems.
  • Supports the promotion of effective communications, a high level of client satisfaction and aids in balancing conflicting priorities.
  • Ensures/supports end product quality in conjunction with relevant regulatory requirements 

 

Job Dimensions:

  • Lead the quality of own programming work as well as the completeness of applicable quality and process documentation.
  • Accountable for good Information Practice on all assigned activities.
  • When deployed to a drug project team, operates under the leadership, direction and oversight of a Global Product Programmer (GPP) or her/his delegate.

 

Qualifications:

  • BSc in mathematics, statistics, engineering, computer science, or life or social sciences.
  • Solid experience in the RWE space in SAS, plus R proficiency (ideally) with registry/observational study experience and exposure to RWD Data sources (EMR, claims, etc.)
  • Knowledge of database set-up and report publishing requirements.
  • Advanced knowledge of technical and regulatory requirements related to the role.
  • Knowledge of RWA Data  models and industry best practices.
  • Advanced knowledge and experience of clinical drug development or healthcare and RWA
  • Develop and deliver training.
  • Able to demonstrate team working and role leadership skills appropriate to level.

 

Desirable:

  • Advanced verbal, written, communication and collaboration skills.
  • Advanced problem solving and conflict resolution.
  • Helps drive others to work across global & functional boundaries.
  • Travel – willingness and ability to travel domestically and/or internationally.
  • Ability to apply programming knowledge and skills to problems and quality focus.  Troubleshoots for team.
  • Contributes to defining business processes and accurately completes and manages associated documentation.
  • Team commitment: prioritize attendance at appropriate project team meetings; take steps to understand and appreciate the roles, skills and strengths of others on the team.
  • Diligence – attention to detail and ability to manage concurrent projects and activities within those projects.

 

Key Core Capabilities:

  • Interpersonal
  • Business Relationship Management
  • Change Enablement
  • Flexibility/Adaptability
  • Influencing
  • Initiative
  • Innovation
  • Environmental
  • Business Awareness/Acumen
  • Process Management
  • Core Business
  • Evaluation and Analysis
  • Information and Knowledge Management
  • Project Management

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.


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