Mar 30, 2022

Job Description

40 + different analysis including clinical trials, scientific analysis, health authority responses, publication requests, patient access services, etc., are being worked upon at any point of time. The Statistical Programming team is a dynamic function where we are empowered to experiment, explore, and progress beyond the boundaries of best-in-class Statistical Programming analysis. From a collaborative effort with Data Management, Clinical Study Teams, Statisticians, medical / scientific writing teams, publication teams, we analyze tons of data, deriving meaningful insights that enable us to deliver innovative medicines to millions of patients worldwide.

Your key responsibilities:
Your responsibilities include, but are not limited to:

• Build and Lead a Statistical Programming group by supervising the recruitment, onboarding, development, mentoring and coaching of team-members, with an emphasis on encouraging top talent and promoting synergy and collaboration.

• Ensure effective project management using tools like SNOW for work assignment, status tracking, project completion, capacity calculations and team utilization across NGSCs. Be the Operational Manager of team leads technical experts, senior principal, and principal statistical programmers. Provide performance management, supervision and advice on operational expertise and processes.

• Forge partnerships with technical leaders within other functional areas (e.g., GDD, GDO, RWE, DSAI) to keep abreast current best practices in clinical reporting. Own the decision‐making process for establishing multidisciplinary project/program goals within Biometrics.

• Ensure and support the highest level of collaboration across different team locations and between functions. Set group objectives, evaluate team performance in conjunction with the Biometrics leadership team. Manage team budget, including approval of expenses and vendor and contractor management.

• Audits and Compliance, provide input, review, and maintenance to working practices and standards, as needed. Ensure team is audit / inspection ready and compliant to NVS / regulatory requirements. Establish and maintain efficient interfaces at project level with internal and external customers with support of CONEXTs management.

• Ensures scientific/technical leadership at the trial/project level. Contribute to planning of data analyses and presentation to be used in various forums. Supervise outsourcing to external partners, includes contractual / budget management. Ensure initiatives for process improvements or new technology implementation are taken up as per organization needs.

Diversity & Inclusion / EEO

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

Minimum Requirements

Minimum Requirements:

• 12+ years industry/ proven experience (10 years for MS Statistics / Computer Science/ Health Science graduates).

• Knowledge of / experience with SAS and other relevant programming software. Ability to operate effectively in a global environment. Attention to detail and quality focused.

• Established track record of active contributions within the line function as well as ability to contribute to matrix teams with the necessary critical thinking, quality awareness and implementation skills.

• Excellent understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH) across disease areas.

• Advanced knowledge of office tools. Working knowledge of database design/structures and basic statistics. Good understanding of global / project practices, procedures, methodologies.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to tackle the world’s toughest medical challenges aggressively and ambitiously. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
Hyderabad, AP
Research & Development
Full Time
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Group Lead, Statistical Programming

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