Senior Statistical Programmer

il y a 2 jours

Brainel'Alleud, Belgique UCB S.A. Temps plein

**Make your mark for patients**

At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We look to transform patients’ lives by pushing the boundaries of what is possible. With us, our talent makes the most of who they are, unlocking innovation and setting new standards for patients.

Everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” And to find the answers, we connect globally with patients and their families living with the physical and social burdens of severe disease. These connections give us new perspectives, drive our innovation, and offer a hope for a new generation of therapies that will help to transform lives.

To strengthen our Patient Value Development Solutions, Statistical Sciences and Innovation team, we are looking for a talented individual to fill the position of Senior Statistical Programmer. The role can be based in either Braine, Belgium or Slough, UK.

As a senior statistical programmer, job responsibilities may include:

- serving as a program or study-level programmer in a defined development program for a UCB mission,
- supporting the programming and analysis of a clinical study within current or future UCB compounds or across multiple compounds/areas of research,
- serving as a lead developer of new technologies, such as innovative visualization techniques or other non-traditional pharmaceutical programming.

Main accountabilities:

- Leads and supports statistical programming activities for assigned clinical studies, health authority submissions and development initiatives. Coordinates and provides input as point of contact, for assigned projects and study teams.
- Programs, validates, maintains, and documents statistical and analysis programs for asset development on the basis of the Statistical Analysis Plan and other documents following UCB standard operating procedures and industry standards (CDISC).
- Manipulates and analyses various data types related to clinical trials across multiple tools and using different programming languages, where appropriate.
- Where applicable, develops innovative programming methodologies (i.e. interactive visualization, dashboards, etc.) to facilitate easier interpretation.
- Ensures that submission package and study datasets (SDTM and ADaM), tables, figures, listings, statistical outputs, and program documentation meet standards requirements of regulatory agencies and other departments within UCB.
- Provides proactive and effective collaboration for statistical programming initiatives.
- Proactively supports the development of Statistical Programming Vision at UCB.
- Supports direction, motivation, and oversight of statistical programming resources (internal and external) for timely delivery of all statistical programming outputs.
- Supports development and rollout of new standards and processes with respect to own statistical programming operations team.
- Mentors statistical programmers within SSI.
- Works within a global team respectful of multiple cultures and countries.
- Effectively communicate, present ideas well online, read the virtual room, and connect with others virtually.

Interested? For this position you’ll need the following education, experience and skills:
Education - experience:

- 3+ (with Master’s degree) to 5+ (with Bachelor’s degree) years in statistical programming within the Biotechnology and/or Pharmaceutical Industry (including clinical research organizations) with proven successful track record in pharmaceutical development.
- Excellent understanding and profound knowledge of statistical programming aspects required for regulatory submissions.
- Expertise in SAS, R, python and/or other programming languages.
- Excellent in written and spoken English.

Specific skills:

- Proficient (Advanced) SAS, R, python and/or other programming languages, including experience with development of dynamic and reusable code.
- Proficient expertise in manipulating and analyzing various data types related to clinical trials.
- Proficient knowledge of SDTM and ADaM programming requirements. Ability to define and implement new SDTM and ADaM domains into clinical studies practices.
- Good clinical studies design and analysis experience, including comprehensive understanding of drug development phases, clinical studies designs, efficacy endpoints and safety endpoints and assessments.
- Working knowledge of statistical principles, including descriptive and inferential statistical (parametric and non-parametric) methods.
- Good understanding of regulatory submissions requirements for new product development and support.
- Demonstrated experience in leading and participating in collaborative work teams at local and global levels, preferably including CROs.
- Good leadership abilities and interpersonal skills to mentor and lead statistical programmers to successfully deliver high quality project.

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