Prepare analysis plans and write detailed specifications for analysis files, tables, listings and figures.
Interpret analyses and write statistical sections of study reports.
Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy.
Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for each task undertaken.
Checks programming logs for cleanliness and correct processing of data.
Inputs into Data Issues log and follows issues to appropriate resolution.
Perform statistical team lead role on single studies.
Works closely with the Project Team Lead and supervisor to deliver on time, with high quality and within budget.
Build and maintain effective customer relationships, driving statistical discussions, providing support and/or guidance for statistical activities.
Acts as a lead in meetings, documenting where necessary and following up on actions.
Actively participates in internal project team meetings.
Plans and documents timelines, forecasts resource needs, suggests work that may be out of scope.
Shares accountability for the financial success of assigned studies.
Identifies risks to project delivery and/or quality and proposes solutions to mitigate risks.

Bachelor's Degree Biostatistics or related field and 1
3 years relevant experience Req
Master's Degree Biostatistics or related field and 1-3 years relevant experience Req
Ph.D. Biostatistics or related field Req
Typically requires 1-3 years of prior relevant experience, or equivalent combination of education, training and experience.
Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.
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.
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 Clinical Data Interchange Standards Consortium (CDISC)/ADaM).

Biostatistician 2

Key skills