Principal Statistical Programmer (m/f/d)

Job Description Summary

The Principal Statistical Programmer is responsible for all aspects of statistical programming of a large/critical study, multiple studies or activities at project level (including the submission activity) for all assigned in house studies as well as all assigned outsourced projects. This is a critical role in ensuring that Sandoz Biopharma Clinical Development plans are executed effectively, with timely, high quality results.

 

Job Description

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!

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

You’ll receive:

Sandoz has an employee-first approach and that’s why your personal growth is so important to us. You will have access to Coursera and other learning platforms with more than 200,000 learning videos and 5000+ courses.

In addition to the various learning opportunities, we offer company benefits, such as:

• 30 days of annual leave
• Holiday allowance
• Additional rewards for special occasions (e.g. service length awards, marriage celebration, etc.)
• Company pension schemes and capital formation benefits
• Parental leave
• Other offerings, such as bike leasing

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! 

The future is ours to shape!

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Join our Sandoz Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Sandoz and our career opportunities, join the Sandoz Network here:  https://talentnetwork.novartis.com/sandoztalentpool

#Sandoz

 

Skills Desired

Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, Programming Languages, Reporting, Statistical Analysis