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Biostatistician - Clinical Practice (4-14 yrs)
ob Title : Bio Statistician 2
Prepare analysis plans and write detailed specifications for analysis files, tables, listings and figures. Interpret analyses and write statistical sections of study reports. Provide training, guidance and mentorship to lower level and new staff.
- Develop analysis plans, table shells, programming and table specifications; produce tables, listings and figures; perform data review and statistical analysis.
- Assist with protocol development, sample size calculation, protocol and case report form (CRF) review.
- Advise data management staff on database design, and critical data. May advise on validation checks.
- Write statistical sections of integrated reports.
- Under supervision, act as statistical team lead for single studies.
- 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.
- Assist with review of RFPs and QIPs; prepare proposal text. May participate in bid defense meetings.
- Provide training and guidance to lower level and new staff.
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
- In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials
- Strong individual initiative
- Strong organizing skills
- Strong working knowledge of SAS computing package
- Familiarity with other relevant statistical computing packages such as StatXact
- Strong commitment to quality
- Ability to effectively manage multiple tasks and projects
- Ability to provide and 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)
JOB DESCRIPTION :
MINIMUM REQUIRED EDUCATION AND EXPERIENCE :
- PhD in biostatistics or related field; Master's degree in biostatistics or related field and 4 year relevant experience; Bachelor's degree or educational equivalent in biostatistics or related field and 3 years relevant experience; or equivalent combination of education, training and experience
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