Job Title : Bio Statistician 1

PURPOSE :

- Prepare analysis plans and write detailed specifications for analysis files and tables/figures/listings. Write statistical section of study reports and provide general statistical analysis support for project teams. Provide guidance to lower level and/or new staff.

RESPONSIBILITIES :

- Develop analysis plans, table shells, programming and table specifications; produce tables, listings and figures; perform data review and statistical analysis.

- Assist with protocol development and protocol and case report form (CRF) review.

- Advise data management staff on database design and critical data. May advise on validation checks.

- Assist in writing statistical sections of integrated reports.

- Assist project lead in fulfilling project responsibilities.

- Understand the Scope of Work, budget and quote assumptions, estimate the work completed, and manage scope for single studies. May manage project budget and resource requirements and provide revenue and resource forecasts for single studies, under supervision.

- Provide guidance to lower level and/or new staff.

- Under supervision, act as statistical team lead.

All responsibilities are essential job functions unless noted as nonessential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES -

- Excellent written and oral communication skills including grammatical/technical writing skills

- Excellent attention and accuracy with details

- Familiarity with basic statistical methods that apply to applicable clinical trials

- Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

- Strong individual initiative

- Strong organizing skills

- Aptitude for, and working knowledge of SAS computing package

- Strong commitment to quality

- Ability to effectively manage multiple tasks and projects

- Ability to accept direction of lead team members

- Ability to solve moderately complex problems

- Ability to establish and maintain effective working relationships with coworkers, managers and clients

- Working knowledge of relevant Data Standards (such as CDISC/ADaM)

MINIMUM REQUIRED EDUCATION AND EXPERIENCE :

- Master's degree in biostatistics or related field

- Bachelor's degree in biostatistics or related field and 4 year relevant experience; or equivalent combination of education, training and experience

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