Team Lead - Biostats

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 Biostatisticians work on real world data/ evidence or clinical trials on Gene therapy-based drug products or apply adaptive designs to find new biomarkers or automate devices for diagnosis. From a collaborative effort with Data Management, Clinical Study Teams, Statisticians, medical / scientific writing teams and publication teams, we analyze tons of data, deriving relevant insights that enable us to deliver innovative medicines to millions of patients worldwide.Your responsibilities include, but are not limited to: Lead and build a high-performing global Biostatistics group by overseeing the recruitment, onboarding, development, mentoring and coaching of Biostatistics Team Leads and team-members, with an emphasis on fostering top talent and promoting synergy and collaboration. Ensure and support the highest level of collaboration across different team locations and between Biostatistics Team Leads. Set group objectives, manage and evaluate team performance in conjunction with the Biometrics leadership team. Manage team budget, including approval of expenses and vendor and contractor management. Provide input, review, and maintenance to working practices and standards, as needed. Lead the PLSS statistical analytic contributions to the clinical studies/ projects in collaboration with the Lead Statistician(s) on projects, comprising all relevant technical and disease area knowledge. Work with lead statisticians and programmers to provide statistical analytic solutions for clinical study reporting. Provide statistical analytic support to the lead statistician(s) for the data pooling strategy and develops the detailed statistical methodology, as needed, Establish and maintain efficient interfaces at project level with internal and external customers with support of PLSS management; Drive operational excellence by providing input to standard programs (which can be re-used) in collaboration with the programmers and lead statistician(s) for all studies. Provide input to develop computational environment/systems which are GxP compliant. Takes an active contributing role in PLSS initiatives and forums. Minimum requirements Proven in up-to-date statistical knowledge/ applications and expert in statistical computation aspects. A deep understanding of drug development, ICH and HA guidelines. MS/ MSc (in Statistics or equivalent) with 11+ years relevant work experience or PhD (in Statistics or equivalent) with 8+ years of work experience Excellent knowledge of / experience with SAS/ R/ Splus or any other business or statistical computation software. Establish track record of trouble shooting skills including significant data driven decision making support. Solid experience in leading statistical analytic support for project(s), including tasks related to MAPs and submission activities. Strong team skills. Lead local team of Statistics 5-10 associatesWHY 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 whats possible, when we collaborate with courage to aggressively and ambitiously tackle the world s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!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.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,

Keyskills :
data managementclinical trialsteam performancedrug developmentscientific writingscientific analysiscareer opportunitiesoperational excellenceproject administration