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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 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:

• Lead programmer and primary point of contact for a clinical trial protocol.

• Provides technical expertise for statistical programming, automated report development, and submission data standard packages.

• Supports statistical programming activities for large/complex drug/vaccine clinical development projects.

• Accountable for the development and execution of statistical analysis and reporting deliverables, such as safety and efficacy analysis datasets, tables, listings, and figures.

• Performs data manipulation, analysis, and reporting of clinical trial data (ISS/ISE) using SAS programming.

• Generates and validates SDTM and ADaM datasets/analysis files, as well as tables, listings, and figures (TLFs).

• Conducts production and QC/validation programming.

• Generates complex ad-hoc reports using raw data.

• Applies strong understanding of efficacy analysis.

• Creates and reviews submission documents and eCRTs.

• Communicates with internal teams and clients regarding project specifications, status, issues, or inquiries.

• Performs lead duties when called upon and serves as a team player, ensuring results and meeting deadlines.

• Adapts to changing priorities with flexibility.

• Designs and maintains statistical datasets supporting multiple stakeholder groups.

• Collaborates with statistics and other project stakeholders to ensure efficient execution of project plans and timely, high-quality deliverables.

• May serve as the statistical programming point of contact throughout the product lifecycle for the assigned protocol.

• Develops and validates analysis and report programming using global and TA standards, departmental SOPs, and best programming practices.

• Coordinates supplier programming activities and interacts with Merck statistical programmers.

• Demonstrates strong project management and leadership at the protocol level, ensuring consistency and guiding the development of others when opportunities arise.

• Designs and develops complex programming algorithms.

• Understands analysis plans, statistical methodology, and relevant terminology.

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, Life Sciences etc.

• At least 7 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.

• Proficient level of R-programming experience.

• 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, reviewers guide and other submission documents.

• Experience supporting immunology, respiratory or oncology 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.

• Ability to provide solutions for complex programming issues (including creation of complex macros), presenting alternatives and identifying best solution.

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.