Senior Biostatistician Job in Phoenix Human Capital Pvt Ltd.

Job description

RESPONSIBILITIES

• 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 and justification, protocol and CRF review.
• Advise data management staff on database design, and critical data. May advise on validation checks.
• Write and review 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).
• Act as statistical team lead for single complex studies or groups of studies.
• Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. May manage project budget and resource requirements.
• Provide support in preparation of RFPs and QIPs.
• Provide training and guidance to lower level and new staff.
• Any other responsibilities as assigned by the management in liaison with the organization need

MINIMUM REQUIREMENTS

• Masters Degree in Statistics/ Applied Statistics/ Biostatistics
• 3-7 years of relevant experience

SKILLS

• 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
• Familiarity with moderately complex statistical methods that apply to applicable clinical trials
• Strong individual initiative and organizing skills
• Thorough understanding of SAP and mock shell creation & review
• Good knowledge on creation and review of Safety and Efficacy data analysis
• Good understanding of designing or providing input to the Protocol
• Strong working knowledge of SAS computing package
• Familiarity with other relevant statistical computing packages such as nQuery
• 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 co-workers, managers and clients
• Working knowledge of relevant Data Standards (such as CDISC/ADaM)