Director Biostatistics / Associate Director Biostatistics

PAREXEL International

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Location: Billerica, MA Posted Date: 4/15/2013 Position Type: Full time Job Code: pare-10025511 Required Education: Doctorate/PhD Areas of Expertise Desired: Biostatistics

Description

Director Biostatistics / Associate Director Biostatistics

Do you possess cutting edge biostatistics experience and a thorough understanding of statistical issues in clinical trials? We are currently seeking recognized industry leaders to with submission experience to identify, develop and successfully implement strategic initiatives, and consult with clients on technical, statistical or regulatory issues. Individuals will oversee and be involved with the production of clinical trial reports and in the provision of statistical services. Opportunities are client-facing, and will involve your participation in capabilities presentations and bid defenses, general customer meetings, consultancy meetings with customers as well as meetings with regulatory authorities.

Keywords: statistician, biostatistics, statistical, statistics, biostatistician, tables, listings, figures, sap, Bayesian, clinical trial, clinical study, clinical studies, biostatistics, clinical programming, bid defenses, client meetings, global trials, global studies, FDA, regulatory, medical writing, data management, contracts, proposals, pm, project management, project manager, implementation, client interaction, sponsor, pharma, biotech, rfp, rfi

GROWTH: While most companies were busy downsizing, during 2010 PAREXEL opened two new offices and added over 800 employees!

PROMOTION: In 2010, more than 1700 PAREXEL employees received career promotions!!

EXPERTISE: PAREXEL's experts, who have experience across a broad range of therapeutic areas, have supported nearly all of the top 50 best-selling drugs that are on the market today.

AWARDS: PAREXEL was named Company of the Year 2010 for the Pharmaceutical Industry in The Eighth Annual International Business Awards, the only global, all-encompassing business awards program honoring great performances in business. PAREXEL announced that the Company had been included on the 'Best 5'Pharmaceutical' industry sublist 2010 as part of The International Association of Outsourcing Professionals® (IAOP®) annual ranking The Global Outsourcing 100. PAREXEL was recognized as a Best 10 Outsourcing Company for the Pharmaceutical Industry as part of the Global Outsourcing 100® 2010, and also received Scrip Award for Clinical Research Team of the Year.  PAREXEL was recognized as Best Performing CRO 2009 by BioSingapore for its leadership in the Asia/Pacific region, and ranked in the Top 10 among best performing Massachusetts-based public companies in The Boston Globe 100, as well as a Top Employer (ranked by number of worldwide employees)

Requirements

Knowledge, Skills and Traits:
- Thorough understanding of e-submissions - Thorough understanding of eCTD
- Thorough understanding of 21CFR parts 11, 54, 56, 312, and 314
- Thorough understanding of ICH guidelines
- Thorough understanding of regulatory guidance pertaining to specific indications but also to electronic submissions
- Thorough understanding of regulatory data sciences
- Thorough understanding of statistical issues in clinical trials
- Thorough understanding of issues related to adaptive trials
- Acquaintance with Bayesian statistics
- Extensive experience with SAS programming required
- Ability to work independently
- Good analytical skills
- Good project management skills
- Professional attitude
- Ability to work well with others Communication:
- Address technical issues effectively with written and verbal communication
- Explain biostatistical and technical issues effectively to technical and non-technical staff

Education:
- Requires a PhD or equivalent in Biostatistics or a related field and at least 8-10 years experience supporting the design of clinical trials and the analysis and reporting of clinical trials data in the pharmaceutical industry.
- Experience supporting regulatory submissions for pharmaceutical product registration is required.

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