Group Head Biostatistics

Job Description Summary-Biostatistics -Influences and drives statistical strategy/innovation at advanced expert-level directly taking part in cross-functional collaboration & decision making for multiple programs, across multiple indications/therapeutic/disease areas within (pre/early/full) clinical development and/or medical affairs. Responsible for leading and integrating input from different quantitative scientists, impacting clinical development, health authority interactions. Represent the function at internal and external decision boards, develop and mentor other statisticians, and provide strategic, technical, operational and scientific leadership and solutions. -CDS -Supports Head CDS in setting the standards and automation strategy across Novartis. Manage a global team(s) responsible for executing data standards / automation objectives across DO. Responsible for ensuring quality, scalable, reusable, (CDISC and regulatory) compliant data standards and technologies are transparently deployed across GDO in close collaboration with external industry peers and internal stakeholders delivering stellar customer focus. Responsible for planning and overseeing KPIs/metrics, frameworks, policies, business rules and processes for development, maintenance, deployment. Responsible to ensure Novartis fulfills a ROI across the standards and automation landscape.Job DescriptionSandoz 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’ SandozYour Key Responsibilities:Your responsibilities include, but not limited to:Ensure expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, negotiating with pricing agencies, influence and implement publication strategy, quantitative decision making) for critical studies in a programProject level:Accountable for strategic statistical input and influence into one or more projects (development plan, dose-finding strategy, regulatory strategy, publication strategy, pricing & reimbursement strategy, statistical deliverables).May be a core member of GPT representing Biostatistics and Pharmacometrics.Lead collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making in drug development and enable successful impact on robust drug development plans.Collaborate cross-functionally (e.g. data management, statistical programming, medical writing) to ensure timeliness and quality of statistical deliverables.Facilitate seamless transition of projects from early to late development.Effective partnership with other functions to ensure integrated quantitative input into project.Propose and implement innovative designs and methods to optimize drug development.Plan, prioritize and oversee project level activities and ensure efficient resource management within or across franchise and effective partnership with vendors.Drive adherence to organizational standards and regulatory guidelines.Represent Biostatistics and Pharmacometrics line function at internal and external decision boards (e.g. regulators).Significantly contributes to project team preparation and may play a prominent role representing biostatistics at HA Advisory Committees and meetings.Disease Area / TA/Indication level:As partner to senior clinical and scientific leadership, drive strategic statistical input and excellence to drug development within the TA/DA/indications.Franchise or Global Line Function level:Lead or significantly contribute to initiatives at global line function level, or cross-functional franchise level, requiring coordination of diverse of team members.May contribute to line function review.Enterprise level:Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives.Represent Biostatistics in due-diligence teams for low to mid-complexity in-licensing opportunities with minimal supervision.Lead the review and implementation of health authority guidance.Identify, evaluate, and promote the use and the acceptance within and outside the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings.External:Represent biostatistics in interacting with external experts (statistical, clinical, and technical).Chair sessions at professional meetings.People Management:Develop and mentor statisticians.As global manager:

responsible to recruit, retain and, professionally develop up to 10 biostatisticians.What you’ll bring to the role:Essential Requirements:MS or PhD in Biostatistik (or equivalent)MS (in Statistics or equivalent) with 12+ years relevant work experience or PhD (in Statistics or equivalent) with 8+ years relevant work experience.Influences decisions that directly impact the project and departments ability to deliver objectivesHas advanced knowledge of applying statistics and innovative approaches Expert knowledge in a variety of statistical areas.Record of successful implementation of novel methods and/or innovative strategies in drug developmentExtensive knowledge of drug development and HA guidelinesStrong understating of at least one disease areaMay have proven people leadership ability and expert skills in building partnerships and collaborations.Fluent English oral and writtenExcellent communication and presentation skillsGood coaching and mentoring skillsGood business ethicsWhy 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 moreWith 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 shapeCommitment 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: #Sandoz Skills DesiredAutomation Technology, Biostatistics, Clinical Trials, Computer Programming, Cross-Functional Teamwork, Data Analytics, Data Strategies, Decision Making, Metadata Management, Project Management, Statistical AnalysisSummaryLocation: Holzkirchen (Non-Sales Force) (Hexal AG) (Sandoz)Type: Full time

---