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Kelly Services

Cambridge, MA
Job Code:
  • Business Development/Operations
  • Information Systems
  • Data Management
  • Project Management
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Job Details

Job Title Statistician

Jobid US33MXMP_BH1437255

Location: Cambridge, MA, 02238, USA

Description Statistician - Scientific - JOB TITLE: USA - Project Statistician

Responsibility Represent the statistics function in support of Oncology Business Unit OBU related activities, including GMA and Market Access, generally supporting multiple studies at a time.

Provide statistical input to feasibility assessments, development and submission plans, and in support of regulatory submissions.

Provide statistical support with minimal supervision in the development and review of the statistical analysis plan, study report, and other analytical documents, ensuring accurate and statistically valid deliverables.

Implement project level database including derived database , analysis and reporting standards.

Provide suggestions to achieve high quality databases and specifications by working with Data Management and Programming at project level.

Plan and direct study-level analysis and reporting activities eg, tables, listings, graphs including review of work by programmers. Identify study-level vendor requirements and participate in the evaluation/selection of analytical vendors.

Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs.

Review and approve key statistical vendor deliverables.

Anticipate and communicate study level resource and quality issues that may impact deliverables or timelines.

Propose and implement solutions.

Escalate issues to management as appropriate.

Consider and evaluate alternative analysis methodology and data presentation techniques.


Generally requires PhD in statistics or biostatistics with at least 5 years of relevant experience or MS in statistics or biostatistics with at least 7 years of relevant experience. For statisticians with exceptional talent who have demonstrated core capabilities of a Principal Statistician, 3 years of pharmaceutical industry experiences with a PhD in statistics or biostatistics may be considered.

Experience with advanced study design or at least one NDA/CTDs or other global regulatory submissions.

Advanced knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics. Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents.

Extensive knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.

Good knowledge of statistical programming languages including SAS , software, techniques, and processes.

Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS e.g., Microsoft Office products .

Excellent oral and written communications skills.

Strong project management skills.

Strong collaborative skills and ability to work with a cross-functional team, especially with GMA and PMA colleagues.

**Why Kelly?**

**For immediate consideration, if you meet the above requirements, please email a current copy of your CV to or click 'apply now'.**
**You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place.**

**Let Kelly fuel your career—connect with us today.**

_*Available for purchase and administered by a designated third-party vendor_

_Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, and Gender Identity, and is com_

**Why Kelly** **®** **?**

At KellyServices ® , we work with the best. Our clients include 95 of the Fortune100 ™ companies, and more than 70,000 hiring managers rely on Kelly annually to accessthe best talent to drive their business forward. If you only make one career connection today, connectwith Kelly.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 peoplearound the world and have a role in connecting thousands more with work through our global network oftalent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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