Senior/Principal Statistical Programmer - Remote 1

Date: Apr 12, 2024

Location: RO

Company: Cytel Software Corporation

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 a Senior/Principal Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote.

 

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.

 

How you will contribute:

 

  • Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
  • Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures ( TLFs)
  • 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

 

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.
  • Study lead experience, preferably juggling multiple projects simultaneously preferred.
  • Strong SAS data manipulation, analysis and reporting skills.
  • Solid experience implementing the latest CDISC SDTM / ADaM standards.
  • 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.
  • Experience supporting Rare diseases and Gastro Intestinal studies would be a plus.
  • 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.

 

Why Cytel?

 

Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

 

At Cytel, our focus is to provide you with a comprehensive and competitive total reward package. In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

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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