Senior Statistical Programmer FSP-Hybrid 3 days a week in PA a must

Posted 3 Days Ago
Be an Early Applicant
2 Locations
Remote or Hybrid
Senior level
Software • Analytics • Biotech
The Role
As a Senior Statistical Programmer, you will lead and support clinical trials by generating statistical programming deliverables, performing data analysis, and collaborating with cross-functional teams in a pharmaceutical setting.
Summary Generated by Built In
Sponsor-dedicated:
 
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer, you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

 
Position Overview: 

 
As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Early or Late-stage clinical trials. This role is Hybrid office based in PA (Preferred) OR NJ.

 
Our values
  • We believe in applying scientific rigor to reveal the full promise inherent in data.
  • We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.
  • We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
  • We prize innovation and seek intelligent solutions using leading-edge technology.
Responsibilities

How you will contribute:


  • Generating and validating statistical programming deliverables (SDTM, ADAM, TFL's) in Early Development Statistics and PK/PD Modeling and Simulation spanning all therapeutic areas
  • Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
  • Production and QC / validation programming
  • Generating complex ad-hoc reports utilizing raw data
  • Applying strong understanding/experience of Efficacy analysis
  • Creating and reviewing submission documents and eCRTs
  • Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
  • Performing lead duties when called upon
  • Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
  • Being adaptable and flexible when priorities change
Qualifications

Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:    

  • Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
  • At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above.
  • Having experience/expertise working on Early Development studies. Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters).
  • Develop and validate global programming standards for ADaM datasets.
  • Develop and validate global programming standards for efficacy analysis, safety analysis and reporting.
  • Design and develop complex programming algorithms.
  • Experience in one or more of the following will be preferred: R, SPlus, NonMem.
  • Assist project teams in creating SDTM deliverables for Analysis and Reporting (A&R) and submission.
  • Support project teams in preparing submission deliverables including use of Pinnacle 21 Enterprise.
  • Up-versioning activities to specific versions of SDTM.
  • Experience supporting Oncology studies would be a plus.
  • Strong SAS data manipulation, analysis and reporting skills.
  • Solid experience implementing the latest CDISC SDTM / ADaM standards.
  • Knowledge of submission standards CDISC SDTM, Define.XML, SDRG, aCRF.
  • Strong QC / validation skills.
  • Good ad-hoc reporting skills.  
  • Proficiency in Efficacy analysis.
  • Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
  • Submissions experience utilizing define.xml and other submission documents.
  • Excellent analytical & troubleshooting skills.
  • Ability to provide quality output and deliverables, in adherence with challenging timelines.
  • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.

Skills Required

  • Bachelor's degree in Statistics, Computer Science, Mathematics, etc.
  • At least 8 years of SAS programming experience with clinical trial data.
  • Experience with Early Development studies and clinical endpoint data.
  • Experience implementing CDISC SDTM / ADaM standards.
  • Strong QC / validation skills.
  • Experience with R, SPlus, or NonMem is preferred.

Cytel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Cytel and has not been reviewed or approved by Cytel.

  • Healthcare Strength Health coverage is described as comprehensive, spanning medical, dental, vision, life and disability, with FSAs/HSAs also available. Plan quality is often characterized as good to excellent, which lifts the perceived value of the overall package.
  • Retirement Support A 401(k) with employer match is consistently part of the benefits package. The plan is also characterized as well managed, contributing to a sense of baseline retirement support.
  • Fair & Transparent Compensation Overall pay is characterized as decent-to-good and broadly competitive in parts of the business, with stronger alignment noted in senior technical tracks like biostatistics and programming. The total package is often framed as respectable rather than premium.

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The Company
HQ: Waltham, MA
1,395 Employees
Year Founded: 1987

What We Do

Cytel enables decision-makers in the life sciences to unlock the full potential of their products. From navigating uncertainty to proving value, Cytel’s 30 years of global expertise in consulting, data-driven analytics, and industry-leading software helps biotech and pharmaceutical companies transform intelligence into confident decisions. We have an uncompromising commitment to scientific rigor and high standards of operational excellence, which are channeled through our locations in North America, Europe, the United Kingdom, and Asia. Together, we enable our clients to deliver the therapies that propel humanity forward. Cytel employs a range of data science tools from biostatistics to machine learning to help executives in the life-sciences to make confident decisions powered by data. We are probably best known for being leaders in the field of adaptive clinical trial design, a subset of trial design that uses interim looks to enhance the patient safety and commercial value of pharmaceutical products. We also have specialists in Bayesian statistics, real world evidence, artificial intelligence, health economics, and a number of other research fields to ensure that academic and scientific findings can have impact on industry quickly and seamlessly. www.cytel.com

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