Senior Global Localization Program Manager

Welocalize, Inc; Zaragoza; A distancia; EUR 107.000 - 142.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work

Descripción de la vacante

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to support one or more global pharmaceutical trials. You will leverage advanced SAS programming and CDISC SDTM/ADaM standards to develop analysis datasets, tables, listings, and figures, with opportunities to lead projects.

This fully remote role suits candidates with strong data manipulation, efficacy analysis experience, and a proven ability to deliver high-quality outputs on tight timelines.

Formación

• 8+ years SAS programming experience with clinical trial data in Pharma/Biotech; bachelor’s degree or equivalent; 6+ years with a master’s degree or above.
• Study lead experience, juggling multiple projects is preferred.
• Strong SAS data manipulation, analysis and reporting skills.
• Solid experience implementing CDISC SDTM/ADaM standards.
• Strong QC/validation skills and good ad-hoc reporting.
• Proficiency in efficacy analysis and submissions (define.xml).
• Experience supporting immunology, respiratory or oncology studies is a plus.
• Excellent analytical and troubleshooting skills; able to meet tight timelines with global teams.

Responsabilidades

• Perform data manipulation, analysis and reporting of clinical trial data (safety and efficacy) using SAS.
• Generate and validate SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs).
• Production and QC / validation programming.
• Generate complex ad-hoc reports from raw data.
• Apply strong understanding of efficacy analysis.
• Create and review submission documents and define.xml.
• Communicate with internal cross-functional teams and client for project specs and status.
• Perform lead duties when called upon.
• Be a team player and adapt to changing priorities.

Conocimientos

SAS programming

CDISC SDTM/ADaM

Data analysis

Data manipulation

Ad-hoc reporting

QC/validation

Efficacy analysis

Leadership

Cross-functional teamwork

Communication

Educación

Bachelor's degree in Statistics, Computer Science, Mathematics

Master's degree or above preferred

Herramientas

R programming

Descripción del empleo

Senior/Principal Statistical Programmer SAS + R (Remote)

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

• 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

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.
• 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 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.

Cytel Inc. is an Equal Employment / Aff Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 6 years of related experience with a master's degree or above.