Biostatistician

Client is ramping up their hiring in the Life Sciences vertical and is looking for Biostatisticians to enable our projects with a key account.

Job Description
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, resource requirements, 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
In-depth knowledge of applicable clinical research regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials
Strong working knowledge of SAS computing package
Familiarity with other relevant statistical computing packages such as Stat XACT
Working knowledge of relevant Data Standards (such as CDISC/ADaM)