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Director Biostatistics Medical Affairs, Real World Data Expert

3 months ago


London, Greater London, United Kingdom Novartis Farmacéutica Full time
Director Biostatistics Medical Affairs, Real World Data Expert

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.

Represent the function at internal and external decision boards, develop and mentor other statisticians, and provide strategic, technical, operational and scientific leadership and solutions.

-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.

We are investing in new technologies and building specific therapeutic areas and platform depth and capabilities – all to bring our medicines to patients even faster.

We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.

Novartis are seeking a highly skilled and motivated individual to join our team as Director Biostatistics supporting Medical Affairs as a Real World Data Expert.

You will be required to influence and drives statistical strategy/innovation directly taking part in cross-functional collaboration and decision making for program(s) medical affairs.

Represent the biostatistics function at internal and external decision boards, develop and mentor other statisticians, and provide strategic, technical, operational and scientific leadership and solutions to the organization.

Individual contributor who is a thought leader in Real World Data analysis, drug development biostatistics across related indications/areas
Lead statistician for a mid to high complexity project and/or multiple late phase clinical projects supporting Medical Affairs

This role offers hybrid working, requiring 3 days per week or 12 days per month in our London Office.

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 program, with emphasis on analysis and interpretation of Real World Data

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, Real World Data).

Facilitate flawless transition of projects from early to late development.

Plan, prioritize and oversee project level activities and ensure efficient re-source management within or across franchise and effective partnership with vendors.

MS Statistics or equivalent with 12+ years' work experience or PhD (in Statistics or equivalent) with 8years + work experience with expertise in Real World Data analysis methodology.

Fluent in English with strong communication and presentation skills, with the ability to articulate complex concepts to diverse audiences.

Influences decisions that directly impact the project and department's ability to deliver objectives.
Record of successful implementation of novel methods and/or innovative strategies in drug development.

Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you.

Commitment to Diversity & Inclusion :

Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.


Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you.

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Business Unit Pharmaceuticals
Company / Legal Entity GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.
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