Senior Biostatistician Jobs

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Job Title: Senior Biostatistician

Job Location: United States or Canada - Remote

Job Overview:

Provides biostatistical services to meet the requirements of all Company’ s clients, including full-service, Global Clinical Analytics (GCA), and other type studies. This may include but it’s not limited to: development and approval of Statistical Analysis Plans and table shells, randomization schemes, review of data management documentation, lead development of Protocols and approve the statistical section in Clinical Study Reports, serve as Quality Control Biostatistician or IDMC statistician. The Senior Biostatistician I will act independently for most projects.

Job Duties and Responsibilities:

Meets all the job duties, responsibilities, and requirements of a Biostatistician in addition to those listed here.

• Coordinate and approve TFL and derived datasets, programming of derived datasets and Tables, Figures and Listings (TFL), and data review and statistical analysis developed by Biostatistics and Statistical Programming staff.
• Provide staff training and study oversight as requested by line manager.
• Lead protocol development work including experimental design, randomization, sample size calculation, statistical methods, defining study objectives and parameters.
• Serve as Quality Control Biostatistician for sample size calculation reports.
• Coordinate and approve the statistical section of the Clinical Study Report (CSR) written by Biostatistics staff and collaborate with Medical Writer in preparing the integrated CSR as needed.
• Serve as IDMC / DSMB statistician as needed.
• Coordinate and approve Statistical Analysis Plans (SAP), table shells, programming and derived dataset specifications developed by Biostatistics and Statistical Programming staff.
• Provide staff oversight as mutually agreed with line manager.
• Provide management of other Biostatistics Department requirements and functions, such as SOP updates, as requested by line manager.
• Other duties commensurate with the position as assigned by line manager.

Supervisory Responsibilities

No supervisory responsibilities.

Job Requirements:

• Education

o PhD or Master’s in statistics or related area, or equivalent degree globally

• Experience

o PhD + 3-5 years (or MS + 5-7 years) experience in pharmaceutical, CRO, or related environment.

• Ability to find needed written resources and interact with other Biostatistics staff with the needed familiarity.
• Ability to effectively learn and handle new or unfamiliar statistical methods.
• Interpersonal and communication skills: Excellent written and oral communication skills including technical writing of all statistical results.
• Skills/Competencies
• Willingness to share expertise with younger staff members.
• Ability to develop professional presentations for presenting statistical issues and solutions to clients internally.

• Support the Business Development process through RFP process, bid defenses, attendance at scientific meetings, etc. #LI-IF1 #LI-Remote
• Excellent training and presentation skills: Has the ability to clearly communicate statistical concepts and successfully train and develop staff through coaching and presentations.
• Ability to serve as a Project Manager for GCA studies. Coordinate keeping tasks and project activities in line with agreed timelines and budget.
• Develops capability for interacting with regulatory agencies on behalf of sponsor matters. Such capability would include ability to write statistical reports and/or present oral arguments to such agencies.
• Strong understanding of departmental and company procedures which relate to tasks that are performed routinely: Strong understanding of all departmental SOPs and good understanding of all required company SOPs.
• Familiarity with Company Functional Areas that Biostatistics interacts with on a regular basis (Proposals, Finance, Clinical Operations, Data Management, Medical Writing), and updates appropriate personnel regarding project scope changes which may impact their areas.
• Has strong knowledge of GCP and ICH guidelines and other regulatory guidelines related to statistics.
• Capabilities
• Excellent broad ranging understanding of statistical methods and issues.
• Deep working knowledge of clinical drug development process: In-depth understanding of phases of clinical trials and relevant statistical considerations that apply to Phase I-IV studies and non-inferiority concepts.
• Ensures statistical quality: Reviews and monitors quality of statistical tasks and project deliverables provided by statistical project team.
• Has a developed expertise in 1-2 therapeutic areas.

The company will not accept unsolicited resumes from third party vendors.