Biotech and Pharmaceutical
News and Jobs
eNewsletter Signup
Miles
Km80.5

Asc Director Biostatistics

Novartis Pharmaceuticals Corporation

Apply
Location:
East Hanover, NJ
Posted Date:
4/16/2014
Position Type:
Full time
Job Code:
134257BR
Salary:
Required Education:
Bachelors Degree
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.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. Our policies are not to discriminate in recruitment, hiring, training, promotion or 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.

This position will be filled at a level commensurate with experience. Local candidates preferred
Minimum requirements  Master Degree in Statistics (or equivalent degree) with at least 7-8 years of relevant experience or PhD in Statistics with at least 4-6 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.

Requirements

Master Degree in Statistics (or equivalent degree) with at least 7-8 years of relevant experience or PhD in Statistics with at least 4-6 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.

By applying to/saving a job using , you are agreeing to comply with and be subject to the Terms of Use for use of our website. To use our website, you must agree with the Terms of Use and both meet and comply with their provisions.




//-->