Senior Biostatistician Porto

Senior Biostatistician
Porto
Porto, Porto, Portugal

At Capgemini Engineering , the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to
- saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

YOUR ROLE:

The Senior Biostatistician collaborates with team members (both internal and external) to provide
- quality, reliable statistical expertise and support.

Additionally. they perform and oversee quality control (QC) of data displays with inferential statistics. Also, Senior Statistician conduct QC analysis datasets prepared by others, maintain project administration files (including protocols, annotated CRFs, statistical analysis plans, annotated shells, programming/QC rules, tracking logs, and project communications).

Contribute to design, analysis and reporting of clinical trials or other scientific research studies. Assist with development of protocols, statistical analysis plans and/or Table Figure, and Listing shells with details for execution and programming implementation. Work under supervision to implement sound statistical methodology in scientific investigations.

Write and Review SDTM and ADa
M Specifications for moderately complex studies.

Perform Production and/or Validation Programming of SDTM, ADa
M and TLFs for moderately complex studies.

Assist in identifying scientifically appropriate data collection instruments. Identify and report data issues or violations of study assumptions. Provide programming specifications for derived variables and analysis datasets. Collaborate with team members in preparation for database lock.

Maintain a working knowledge of regulatory guidelines regarding clinical trial analysis and reporting.

With supervision perform statistical analyses as per the analysis plan. Collaborate with Statistical Programming to ensure the delivery of
- quality outputs according to agreed upon timelines.

Evaluate the appropriateness of available software for planned analyses and assess needs for potential development of novel statistical methodology.

With supervision, develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures. Ensure the accuracy of the statistical component of scientific reports and/or publications with high quality. Work collaboratively with
- functional teams. Clearly explain statistical concepts to
- statisticians. Provide responses to questions and pursue analyses suggested by data under supervision.

Build/drive
- functional relationships and collaboration.

Collaboration with US time zones to support periodical sponsor meetings and internal questions and meetings.

YOUR PROFILE:

• Master’s degree in statistics, biostatistics or closely related fields, Ph
  D preferred.
• Master with 4+ years (Ph
  D 1+ year) of industry experience as a Study Statistician
• Ability to lead projects and manage team members and work collaboratively, effectively, and productively in diverse organization structures.
• Solid statistics background and training, working knowledge of advanced statistical methodologies and SAS programming skills; good understanding of drug development and experiences with clinical trial data analyses/preparation for submissions; good knowledge and understanding of regulatory guidelines
• Advanced knowledge of SAS procedures.

What Will You Love About Working Here:

• Join a multicultural and inclusive team environment.
• Enjoy a supportive atmosphere promoting
  - life balance.
• Hybrid work.
• Your career growth is central to our mission. Our array of career growth programs and diverse professionals are crafted to support you in exploring a world of opportunities.
• Access valuable training and certifications in
  - edge technologies.
• Engage in exciting national and international projects.
• Health and life insurance.
• Referral program with bonuses for talent recommendations.
• Great office locations.

About Capgemini

Choosing Capgemini means choosing a company where you will be empowered to shape your career in the way you’d like, where you’ll be supported and inspired by a collaborative community of colleagues around the world, and where you’ll be able to reimagine what’s possible. Join us and help the world’s leading organizations unlock the value of technology and build a more sustainable, more inclusive world.