Senior Biostatistical Programmer

Functional Services Waltham, Massachusetts


Description

Position at Premier Research Group Limited

Premier Research, a mid-size clinical research and consulting organization, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medicines.

Its 1,500 employees, operating in 84 countries across six continents, specialize in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.

Whether it's developing product lifecycle strategies, reducing clinical development cycle times, securing patient access, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.


We’re looking for a talented Biostatistical Programmer to join our team!

Responsible for overseeing the successful operation of one or more groups within Biostatistics. Maintains responsibility for all assigned projects and direct reports.  May also be expected to mentor associate managers, along with other employees.  It is also expected that the individual participate in informal business development activities.

You'll be Accountable for:

  • Develops SAS programs to generate listings, tables and figures as outlined by mock TLF shells
  • Performs quality control (source code review, double-programming and log review) of SAS programs
  • Develops SAS programs to generate CDISC and other analysis data sets as outlined by respective specifications
  • Prepares specifications for CDISC and other analysis data sets
  • Assists Data Management with SAS programming needs
  • Acts as Lead Biostatistical Programmer to interact with the Lead Biostatistician and the study team

You'll Need this to be Considered:

  • BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field or work related experience to be able to perform this role
  • 8+ years of experience in SAS programming within the area of clinical trials
  • Prior experience using computerized information systems preferred
  • Knowledge of ICH and local regulatory authority drug research and development regulations preferred
  • Demonstrated working knowledge of data processing, database design and organization in clinical data environment
  • Demonstrated working knowledge of basic clinical trial design and analysis principles
  • Working knowledge of CDISC standards and application of these standards to projects
  • Working knowledge and understanding of advanced statistical concepts to program analysis datasets and tables which include descriptive and standard/complex inferential statistics
  • Fluent verbal and written English as well as the local language(s) required for clinical trial submissions.
  • Excellent team player, collaborative and able to build an effective team
  • Ability to multitask and work effectively in a fast-paced environment with changing priorities.
  • Is customer service focused in approach to work both internally and externally
  • Maintains a positive, results orientated work environment.
  • Ability to build client confidence and achieving high levels of customer satisfaction
  • Attention to detail and ability to independently work on stand-alone Biostatistical projects with general supervision
  • Must have proven experience with Pharmacokinetic (PK) datasets and analyses
  • Practical experience as lead programmer for pharmacology studies preferred