Principal Biostatistical Programmer

Biostatistics United States Research Triangle Park, North Carolina Boston, Massachusetts Chicago, Illinois Quincy, Massachusetts Denver, Colorado Phoenix, Arizona San Diego, California Philadelphia, Pennsylvania San Francisco, California Portland, Oregon Seattle, Washington Salt Lake City, Utah Austin, Texas Naperville, Illinois Baltimore, Maryland Nashville, Tennessee Atlanta, Georgia Tampa, Alaska Cincinnati, Alaska Pittsburgh, Pennsylvania


Description

Position at Premier Research Group Limited

Wish you were here?  Recognised recently as a Top CRO by Life Science Leader, Premier Research is a medium sized, full service, global CRO with circa 1,500 employees worldwide, perfectly positioned to be big enough to help, yet small enough to care.

 

Premier helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as Oncology, Neurology, Paediatrics, Rare Diseases and Medical Devices, supporting the needs of smaller Pharmaceutical organisations and Biotech companies. There is real opportunity to work across multiple clients on a variety of unique and interesting studies including integrated analyses and regulatory submissions.

 

Continued growth means we are excited to have the chance to add a Principal SAS Programmer to our Biostatistics team.  We can consider office, home based or a mix of the two across many locations. This is a great opportunity to advance your skills (such as high-level consulting work) and grow with a company who recognizes you as an individual in an aspiring, caring and empowering culture.

Interested to join a forward thinking, family feel company which offers real opportunity to add value and help improve patient lives whilst having fun? And at Premier Research, it’s not all work, work, work - across our offices, there are always numerous social & extra-curricular events to get involved in should you so wish, whether it be lunch-and-learns, summer picnics, charity fund raising events, language lessons, or fun contests!

If we hear from you, you’ll hear from us!

As a Sr. level Biostatistical Programmer, you’ll be able to produce project related tables, listings, and graphs (TLG), and integrated summaries of efficacy and safety data for regulatory submissions required for delivery to Premier Research Group clients. You’ll take on lead responsibilities for the development and validation of proprietary SAS Software macros, and advanced statistical programming, supporting large complex Biostatistical projects.  You’ll also have the opportunity to provide Global Biostatistics with advanced programming knowledge and expertise to lead, develop and support programming efficiencies within Global Biostatistics.    

 

What you’ll be doing:

  • Successfully develop and test SAS Software programs to complete complex Biostatistical analyses identified in statistical analysis plans with no supervision.
  • Develop, test, and validate complex Tables Listings, and Graphs for specific projects and project shells in the Global Biostatistics Department.
  • Develop and test SAS Software programs to complete quality control and validation work on SAS Software programs generated by other Biostatistical programmers.
  • Develop and test SAS Software programs using SAS to manipulate and/or import external data into Analysis SAS data sets or export SAS output to other computer files for delivery to clients.
  • Develop SAS Software programs to create derived, complex, Biostatistical parameters and output, derived data sets (e.g., adverse events with multiple merging and cleaning procedures), or other required advanced data manipulation to support completion of Biostatistics projects.
  • Provide lead Biostatistical programming support for integrated summaries of safety and efficacy (ISS and ISE) supporting regulatory submissions that Premier Research is completing.
  • Lead programming tasks using software other than SAS to support Biometrics or specialized data analysis requirements, as assigned.

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.
  • 10 to 12 years of experience in SAS programming within the area of clinical trials with demonstrated working knowledge of basic clinical trial design and analysis principles
  • Strong knowledge of ICH and local regulatory authority drug research and development regulations preferred; Proven working knowledge of data processing, database design and organization in clinical data environment; experience CDISC standards and application of these standards to projects; expertise in advanced statistical concepts to program analysis datasets and tables which include descriptive and standard/complex inferential statistics.
  • Prior experience using computerized information systems preferred
  • Fluent verbal and written English as well as the local language required for clinical trial submissions; strong verbal and written communication and negotiation skills.
  • Known for being a team player and collaborative, maintaining a positive work environment
  • Excellent organizational and time-management skills, able prioritize work to meet deadlines.
  • Accountable, dependable and strong commitment.
  • Is customer service focused in approach to work both internally and externally with the 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.

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