Biostatistician Ii

Thermofisher Scientific; Málaga; Remote; EUR 70,000 - 110,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a sponsor-dedicated engagement with a global pharmaceutical client.

This fully remote role supports Phase I-IV trials and emphasizes CDISC SDTM/ADaM compliance. You will manipulate, analyze and report trial data, lead programming efforts, generate TLFs, and contribute to submissions while collaborating with cross-functional teams.

Qualifications

• Bachelor's degree in statistics, computer science, mathematics, or equivalent.
• 8+ years SAS programming in pharma/biotech with a bachelor's degree or equivalent; 6+ years with a master's degree.
• Strong knowledge of CDISC SDTM and ADaM standards.
• Experience leading data programming and cross-functional collaboration.
• Ability to deliver quality output under tight timelines.

Responsibilities

• Data manipulation, analysis and reporting of clinical trial data using SAS and R.
• Generate/validate SDTM/ADaM datasets and TLFs (tables, listings, figures).
• Lead programming activities and QC/validation.
• Create ad-hoc reports from raw data.
• Prepare submission documents and eCRTs.
• Collaborate with internal teams and client on specifications.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Data manipulation

ISS/ISE analysis

Lead programming

Cross-functional communication

Submission documents

Education

Bachelor's degree in Statistics, Computer Science, Mathematics, or equivalent

Master's degree or above

Tools

SAS

R

CDISC tooling

Job description

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.

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Cytel Inc. is an Equal Employment / Affinity 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.