Senior Manager, Statistical Programming Job Description Template
Our company is looking for a Senior Manager, Statistical Programming to join our team.
Responsibilities:
- 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;
- 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.
Requirements:
- Experience supporting New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs) submissions;
- Knowledge of clinical data analysis and reporting process as it relates to drug development;
- Proficient with Microsoft Office;
- Clinical Data Interchange Standards Consortium (CDISC) experience;
- Demonstrated and applied SAS programming skills (e.g., Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) and a good understanding of database systems;
- Experience working with CROs;
- Excellent written and verbal communication skills;
- 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.