Associate Director, Biostatistics - East Hanover, NJ | Biospace
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Associate Director, Biostatistics

Novartis Oncology

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Location:
East Hanover, NJ
Posted Date:
11/21/2016
Position Type:
Full time
Job Code:
193650BR
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. Uses sound statistical methodology to conduct studies relating to the life processes of plants, animals, and humans. In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. Develops and/or applies statistical theories, methods, and software. Organizes and interprets data into tabular forms amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used. Provide specifications and directions to the clinicians/statistical programmers. May partner in program design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data. Be the statistical leader and project manager for all Biometrics and Data Management (BDM) deliverables globally for a clinical development program,/indication(s) or a highly complex registration trial(s). Ensure that clinical development program (or indication (s) assigned) meets scientific, regulatory, quality and commercialization requirements, through interactions with Global Project Team (GPT) and International Clinical team (ICT). Coordinate and align within BDM (e.g., CDRR, DM, CP, OTM, and GMA) , M&S and represent BDM at GPT, as assigned. Supervise statisticians on the team (as assigned) including settling of objectives, performance management and professional development of associates. Ensure that statistical expertise across Bios (e.g., CP, OTM and GMA) is fully integrated into the project. Understand and contribute to project strategy. Plan, prioritize and track project level activities, including assess and allocate resources. Establish and maintain project standards (e.g. Master Analysis Plan). Plan and manage submission activities, including SCS, SCE, RMP and Briefing Books. Interaction with Health Authorities and external consultants as appropriate. Support and defend analyses and their interpretation at Health Authority Meetings. Represent Biostatistics at FDA Advisory Committee meetings. Could take Indication or Trial Statistician responsibility as appropriate.`
EEO Statement   The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Requirements

PhD in Statistics with at least 4-8 years of relevant experience OR Master Degree in Statistics with at least 7-8 years of relevant experience.

Experience gained in the main tasks of a Senior Statistician (about 2-4 years). Fluent English (oral or written) Proven knowledge and expertise in statistics and its application to clinical trials in at least one TA (preferably Oncology); able to explain statistical designs and concepts. Solid knowledge and experience in drug development process, HA guidelines and submissions. Good knowledge of statistical software packages (e.g. SAS). Very good project management skills. Very good communication and presentation skills. Ability to influence and communicate across functions. Ability to provide effective guidance to Statisticians and coordinate with Programmer/Data Manager. Good team player. Good business ethics. Good leadership skills