Description
RESPONSIBILITIES* Perform, advise, and review protocol development, sample size calculation, protocol and CRF review.
* 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).
* Develop as a primary contact as an expert in at least one therapeutic area including knowledge of therapeutic guidelines.
* Write publications.
* Advise on regulatory issues including integrated summaries of efficacy and safety, and liase with regulatory authorities on behalf of customer as required.
* Fulfill the Advisor/Lead role for a group of studies or integrated summaries. May fulfill the role of regulatory submission lead.
* 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 groups of studies.
* Lead the review of RFPs and QIPs, prepare proposal text and participate in bid defense meetings for groups of studies.
* Develop customer relationships
* Provide training, guidance and mentorship 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
* Advanced knowledge of complex statistical methods that apply to Phase I-IV clinical trials
* Strong individual initiative
* Strong working knowledge of SAS computing package
* Familiarity with other statistical computing packages such as nQuery
* Strong commitment to quality
* Ability to effectively manage and lead multiple tasks and projects
* Ability to lead teams within department and influence interdepartmental team activities
* Proficient at solving complex scientific problems
* Initiative in expanding into new technical areas or expanding in-house technological capabilities in a given area
* 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
* PhD in biostatistics or related field and 5 years relevant experience; Master's degree in biostatistics or related field and 7 years relevant experience; or equivalent combination of education, training and experience
PHYSICAL REQUIREMENTS
* 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