Senior Manager, Statistical Programming

Job Description Summary

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The Senior Manager, Statistical Programming performs the programming activities for clinical development programs and associated clinical studies either directly or through Contract Research Organization (CRO) oversight. Participates in the development of new and review of existing statistical programming standard operating procedures and processes and biostatistics computing systems implementations and application development as appropriate.

 

The incumbent works cross-functionally with internal departments and external resources on statistical programming-related issues.

 

The Senior Manager, of Statistical Programming supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

 

Job Description

ESSENTIAL FUNCTIONS

 

Primary Duties/responsibilities

  • Leads the statistical programming activities for assigned clinical development studies and programs.
  • Ensures timely statistical analyses of clinical data per protocols and Statistical Analysis Plans; either directly or through CRO oversight develops statistical programs and produces programmed outputs used to create integrated scientific reports for clinical trial results
  • Participates in study team meetings as a representative of the Biostatistics function. Communicates statistical issues and acts as a statistical/programming resource to the development teams.

 

  • Participates in the assessment, selection and evaluation of CROs.
  • Participates in the review of Case Report Forms (CRFs), CRF annotations, Statistical Action Plans, TLGs and TLG shells.
  • Interacts with CROs involved in data management/analysis activities to ensure that their statistical analyses and resulting outputs are accurate and consistent with the contractually agreed upon deliverables; works with vendor staff to characterize and resolve issues related to data analysis.
  • Creates/Reviews derived dataset specifications and the related analysis datasets.
  • May develop SOPs and training guidelines related to statistical programming.
  • Performs other tasks and assignments as needed and specified by management.

 

Knowledge/Skills/Abilities Required

  • Minimum level of education and years of relevant work experience.
  • Master’s degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) and a minimum of 6 years of experience in statistics or statistical programming in a pharmaceutical, biotechnology, CRO or related environment.
  • Special knowledge or skills needed and/or licenses or certificates required.
  • Demonstrated and applied SAS programming skills (e.g., Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) and a good understanding of database systems.
  • Working knowledge of R
  • Clinical Data Interchange Standards Consortium (CDISC) experience
  • Knowledge of clinical data analysis and reporting process as it relates to drug development.
  • Excellent verbal and written communication and skills.

 

  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
  • Special knowledge or skills and/or licenses or certificates preferred.
  • Experience working with CROs.
  • Experience supporting New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs) submissions.
  • Travel requirements: 0 – 25%

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