Senior Product Manager, Ai Platform & Ecosystem

Wrike; Islas Baleares; Remote; EUR 107,000 - 161,000; Full time

Job summary

Cytel Inc. seeks a Senior/Principal Statistical Programmer SAS + R for a sponsor-dedicated role embedded with a pharmaceutical client. You will deliver SDTM/ADaM programming and oversee CRO deliverables, ensuring high-quality data outputs for regulatory submissions.

Requirements include a strong SAS and R skill set, extensive CDISC experience, and the ability to work independently with excellent communication and leadership capabilities.

Qualifications

• Bachelor's degree in CS/DS/Math/Statistics required.
• 7+ years of experience as Statistical Programmer in Biotech/Pharma.
• Expert SAS programming skills and CDISC SDTM/ADaM proficiency.
• Regulatory submission experience; ability to work independently.
• Strong communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality programming results using SAS and/or R.
• Oversee CRO deliverables for multiple studies.
• Support clinical study reports, regulatory submissions, publications and DSUR.
• Follow FDA regulations affecting reporting of trial data.
• Develop and maintain standards for programming tools, outputs and macros.
• Contribute to CRF edits, data validation plans and data transfer specs.
• Collaborate to meet project timelines and goals; review SOPs/work instructions.

Skills

SAS programming

Data analysis

Leadership

Biostatistics

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

SAS

R

CDISC (SDTM/ADaM)

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 Principal 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: This position reports to the Director, Biostatistics and Programming in the FSP Services business unit in Cytel. The Principal Statistical Programmer works independently with only concept level instruction and very little supervision, tracks progress, and provides expert technical support to team members. We are looking for a highly experienced senior statistical programmer who will work on clinical development programs on different therapeutic areas and participate in overseeing CRO programmers to ensure that data summaries are delivered in a consistent, high-quality manner. This individual will be responsible for implementing all reporting and analysis activities for the Sponsor clinical trials.

Responsibilities include:

• Generate SDTM, ADaM specifications, datasets, reviewer\'s guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, complex listings, tables, and complex graphs
• Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs
• Participate in overseeing CRO\'s statistical programming deliverables for multiple clinical studies
• Support the preparation of clinical study reports, regulatory submissions, publications, DSUR, and exploratory analyses
• Understand and follow FDA regulations which affect the reporting of clinical trial data
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in the development of CRFs, edit check specifications, and data validation plans
• Provide review and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions to ensure meeting project timelines and goals
• Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices

Qualifications: At a minimum bachelor\'s degree in computer science, data science, mathematics, or statistics; 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Biostatistics team; exceptional SAS programming skills; extensive CDISC (SDTM, ADaM, Define.xml) experience; regulatory submission experience; ability to work independently; strong communication and leadership skills.

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 the following preferred qualifications: experience with pharmacokinetic data and neuroscience; proficiency in languages/tools other than SAS (e.g., R, Python, Java, Shiny, Markdown, Unix/Linux and git).

EEO 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.