BIOSTATISTICIAN

OBJECTIVE:

The purpose of this position is to provide study level statistical expertise by:

• Participate in designing and independently analyzing and interpreting data from clinical studies.
• Using standards to maximize global data integratability and interpretability.
• Leveraging internal and external resources to achieve quality, timely and cost-effective study deliverables.

ACCOUNTABILITIES:

• Represent the statistics function in support of clinical studies.
• Provide statistical input to feasibility assessments, development and submission plans, and support of regulatory submissions.
• Provide accurate, statistically valid deliverables based on study protocols, statistical analysis plans for study reports and regulatory submission documents with minimal supervision.
• 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 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 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.
• Support implementation and development of departmental standards and process improvements.

Qualifications

Please note that the requirements specified in this posting are the basic qualifications required for the Senior Statistician; however, job title will be dependent on the candidate's level of experience in those requirements.

EDUCATION, EXPERIENCE AND SKILLS:

• PhD in statistics or biostatistics or equivalent with minimum of 2 years of relevant pharmaceutical industry experience or MS in statistics or biostatistics or equivalent with minimum of 4 years of relevant pharmaceutical industry experience.
• Good knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics, summarization of data and presentation practices.
• Good knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents.
• Knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials.
• Good knowledge of statistical programming languages (including SAS), software. Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS (e.g., Microsoft Office products).
• General project management skills.
• Good oral and written communications skills.

TRAVEL REQUIREMENTS:

• Access to transportation to attend various meetings held in proximity to the Takeda offices.
• Able to fly to various meetings at investigator, vendor or regulatory agency sites.
• Some international travel may be required.

We are driven to improve people's lives.

www.takedajobs.com

We are an equal opportunity employer

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Schedule
Regular Full-time