Principal Statistical Programmer (m/f/d)

at  Sandoz

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our ‘new’ Sandoz!

Essential Requirements:

• BA/BS/MS or comparable education or international equivalent experience in statistics, computer science, mathematics, life sciences
• Extensive SAS experience and proven skills in using SAS within the statistical programming environment to produce and validate results
• Extensive experience in the participation in statistical analysis plans and/or the construction of technical programming specifications
• Good understanding of industry standards, including CDISC data structures and a solid understanding of the development and use of standard programs
• Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, study procedures)
• Good communication and negotiation skills, ability to cooperate well with others on a global level
• Experience as a trial programmer, including the coordination of internal and external programmers for a specific study/project
• Ideally 5+ years of professional experience as a programmer, preferably supporting clinical studies or in the pharmaceutical industr

YOUR KEY RESPONSIBILITIES:

Your responsibilities include, but not limited to:

• Management of statistical programming activities as Trial Programmer for a large/critical study or several studies or as Lead/Program Programmer for a small or medium-sized project in clinical studies of phases I to IV in Sandoz Biopharma Clinical Development.
• Coordinating the activities of all programmers assigned to the study/project work either internally or externally, assisting other programmers with expertise and procedures decisions/recommendations regarding statistical programming at study or project level.
• Establish and maintain an effective working relationship with cross-functional teams, the ability to summarize the status of deliverables and critical programming aspects (schedules, scope and resource plan) and discuss them, for example, as a member of the Clinical Trial Team (CTT).
• Review of the eCRF, discussion of data structures and participation in data review activities as a member of the CTT.
• Compliance with corporate, departmental and industry standards (e.g., CDISC) and procedures, evaluation and clarification of additional project level programming requirements, review and development of programming specifications as part of analysis plans.
• In consultation with the statistician, responsibility for the development and review of programming specifications for analysis data sets and pooled data sets.
• Ensure the timely and qualitative production and validation of data sets and out-puts for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) according to the specifications in the assigned drug development studies/projects. Where studies are outsourced to an ESP, ensure that they are providing timely and qualitative outputs according to the contract and specifications for the studies assigned to them.
• Responsibility for the quality control and audit readiness for all assigned results from statistical programming and for the accuracy and reliability of the results of statistical analyses. For studies outsourced to an ESP ensure that they have processes in place and are delivering high quality, accurate and reliable results of statistical analyses.
• Providing and implementing solutions in statistical programming; ensuring the ex-change of knowledge.
• Keep indepth knowledge of programming software (e.g. SAS), industry requirements (e.g. CDISC, SDTM/ADaM, eCTD, Define.xml) up to date, participation in functional meetings and training.
• Participates in individual studies in accordance with the agreed contract and internal business guidelines and build successful working relationships with our external ESP partners.
• According to assignment as subject matter expert (SME) or support of process development/non-clinical project initiatives with focus on programming and analytical reporting procedures.

WHAT YOU’LL BRING TO THE ROLE:

Essential Requirements:

• BA/BS/MS or comparable education or international equivalent experience in statistics, computer science, mathematics, life sciences
• Extensive SAS experience and proven skills in using SAS within the statistical programming environment to produce and validate results
• Extensive experience in the participation in statistical analysis plans and/or the construction of technical programming specifications
• Good understanding of industry standards, including CDISC data structures and a solid understanding of the development and use of standard programs
• Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, study procedures)
• Good communication and negotiation skills, ability to cooperate well with others on a global level
• Experience as a trial programmer, including the coordination of internal and external programmers for a specific study/project
• Ideally 5+ years of professional experience as a programmer, preferably supporting clinical studies or in the pharmaceutical industry