Senior Biostatistician - Real World & Late Phase
Develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, consistency checks, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports.
- Coordinate the development of analysis plans, table shells, programming and table specifications, the production of
tables, listings and figures, data review and statistical analysis.
- Perform protocol development, sample size calculation, protocol and CRF review.
- Advise data management staff on database design, validation checks and critical data.
- Write statistical sections of integrated reports.
- Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data).
- Fulfill the Lead role for single complex studies or groups of studies.
- Manage project budget and resource requirements. Understand the Scope of Work, budget and quote assumptions,
estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies.
- Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings.
- Manage customer relationships.
- Provide training and guidance to lower level and new staff.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Excellent written and oral communication skills including grammatical/technical writing skills
- Excellent attention and accuracy with details
- Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials
- Strong individual initiative
- Strong organizing skills
- Strong working knowledge of SAS computing package
- Familiarity with other statistical computing packages such as S , SUDAAN, StatXact
- Strong commitment to quality
- Ability to effectively manage multiple tasks and projects
- Ability to lead and co-ordinate small teams
- Ability to solve moderately complex problems
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
PhD or educational equivalent in biostatistics or related field and 1 year relevant experience; Master’s degree or
educational equivalent in biostatistics or related field and 3 years relevant experience; Bachelor’s degree or educational equivalent in biostatistics or related field and 4 years relevant experience; or equivalent combination of education, training and experience
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
- Occasional travel
Back to top