Senior Statistical Manager, Late Phase

ICON plc   •  

San Francisco, CA

Industry: Pharmaceuticals & Biotech


5 - 7 years

Posted 167 days ago

This job is no longer available.

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

This role sits within our Late Phase team (IIIb/IV) where our Senior Statistical Analysis Manager perform statistical analysis planning, lead statistical analysis, lead statistical reporting, act as overall statistical lead on low to medium complexity studies, participate in business development, and supervise statistical analysis staff.


Overview of the Role

  • Recognize, exemplify and adhere to ICONs values which centers around our commitment to People, clients and performance.
  • As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting clients needs
  • Supports project conception and design.
  • Leads study start-up activities (e.g. reviews, comments on and contributes to study design, protocols, case report forms).
  • Leads the writing of statistical methods sections of study protocols.
  • Leads sample size and power calculations.
  • Leads the review of database specifications.
  • Leads the development of statistical analysis plans
  • Leads the development of table shells.
  • Leads quality control checks throughout programming.
  • Senior oversight of the uploading/downloading of data transfers (internal or external).
  • Senior oversight of initial review of raw variables.
  • Leads the development of written specifications for derived variables from oral descriptions.
  • Senior oversight of the creation of derived variables from written or oral specifications.
  • Leads the selection of appropriate statistical procedures.
  • Senior oversight of the programming of basic statistical procedures.
  • Leads the programming of specialized statistical procedures (e.g., repeated measures, survival analysis, etc.) and/or SAS/Graph.
  • Leads the development of complex macros for use by the group.
  • Leads the design of deliverables, such as site reports, tables, and graphs.
  • Leads the development of deliverables, such as project reports and outputs, graphs, and tables.
  • Leads the creation of abstracts, presentations, and manuscripts.
  • Leads the writing of methods and results sections of final reports and publications.
  • Communicates with the client or investigator as needed..
  • Participates in general marketing conferences or industry meetings.
  • Participates in corporate capabilities presentations, as needed.
  • Participates in professional activities including presentations at technical conferences (e.g. SAS meetings, ISPOR).
  • Leads Statistical Analysis in proposal/RFP development in full-service bids
  • Assists Directors and members of Executive Team with ILPOR initiatives

Role Requirements

  • 4 years relevant experience with a doctoral degree (or local equivalent) or 5 years relevant experience with a master’s degree (or local equivalent).  Prefer 7 years of relevant experience with a doctoral degree (or local equivalent).   In exceptional situations, 7 years relevant experience with a bachelor’s degree (or local equivalent) would be acceptable.
  • Proficient in SAS Data step with simple conditional statements and variable creation.
  • Proficient in performing simple merges and concatenation.
  • Proficient in using complex conditional statements in SAS Data step.
  • Proficient in performing complex merges (including one-to-many merges).
  • Experience using macros and arrays for repetitive tasks.
  • Experience using descriptive statistics procedures for summarizing, restructuring, and outputting data
  • Experience using SAS Output Delivery System to control output from statistical procedures.
  • Proficient in performing analyses using basic statistical procedures.
  • In-depth technical expertise in at least one advanced SAS statistical procedure or technique (e.g., repeated measures, survival analysis, SAS/Graph, advanced macros, etc.).
  • In-depth technical expertise in at least one substantive area (e.g. statistics, epidemiology, pharmacoeconomics, patient-reported outcomes, etc.).
  • Working knowledge of general workplace computer applications such as MS Word, Excel, and PowerPoint.