Manager, Statistical Programming
The Manager, Statistical Programming Manager provides management oversight of personnel and project level activities within the Statistical Programming team and serves as an individual contributor. S/he will have extensive knowledge of data handling and statistical data analysis in both clinical trials and outcomes research. This individual will be responsible for supporting the statistical programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting programs to meet the project’s needs. As a mentor to other programmers, ensures team members adhere to the SOPs, guidelines and local working instructions and assists in the updating of these documents. S/he will work closely with the Leadership of Biostatistics and Programming to provide oversight of the Statistical programming team, project manage deliverables, as well as serve as the programming team lead on clinical study projects.
Principal Responsibilities: (essential job duties and responsibilities)
- Manages Statistical programmers as appropriate, including but not limited to resource planning, recruitment, performance management, progressive discipline, and training need identification.
- Ensures that the programming team meets timelines and provides high quality results
- Sets challenging, achievable goals for direct reports which contribute to department objectives and supports efforts to achieve those goals.
- Provides motivating, timely performance feedback to direct reports on a routine basis as well as for formal performance reviews
- Performs data extracts, data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, SAS/ACCESS Interface to PC Files and SAS/ODS.
- Applies extensive programming expertise in SAS® and other analytical software to clinical trial applications and other non-trial research data to create and analyze clinical data from multiple, primary sources
- Reviews, analyzes and modifies programming systems including coding, testing, debugging and documenting programs.
- Assist in programming, testing, and documenting SAS global utility programs/macros and tools in accordance with standards and validation procedures.
- Perform quality control for programs and other study documents (e.g., presentations and reports).
- Maintain complete and auditable documentation of all programming activities and quality control review process
- Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
- Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles.
- Validate work of other programmer/analysts at CRO or in-house.
- Interact with Statisticians and other clinical/non-clinical team, perform ad hoc analysis and generate outputs according to the requirements.
- Represent Clinical and Statistical Programming in meetings with internal cross-functional and external customers
- Implements and contributes to statistical analysis plans; provides additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.
- Assist Clinical Data Managers with data review via programmed data checks and listings. Assists with MedDRA and WHO Drug coding dictionaries.
- Review core/study configuration, CRFs, DMP, edit check specifications, and table mock-ups.
- Delegate parts of programming development to other team members, providing necessary oversight.
- Engage in process improvement initiative(s)
- Perform activities and tasks as directed by supervisor
- Bachelor’s Degree, Master’s Degree or PhD in computer science, statistics, mathematics, or related field
- Minimum 5 years in a Clinical/Pharmaceutical/Biotech/CRO field
- 6-8 years experience in developing software to analyze clinical data using SAS.
- Must possess strong interpersonal and communication skills, effectively communicating both verbally and in written format.
- Proficient in SAS and SQL (preferred); Proficiency in Base SAS, SAS QC (preferred), SAS Graph, ODS, macro programming
- Successful track record leading project teams
- Preferred Qualifications:
- 7-11 years experience in SAS programming to analyze clinical data
- Minimum 1-2 years management experience
- Demonstrated supervisory and/or management skills
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
- Ability to organize, lead, and motivate teams
- A team player with strong project management and leadership skills
- Self-directed and comfortable working in teams with the ability to work and operate independently
- Advanced skills in SAS programming and statistical reporting
- Preferred knowledge of CDISC standards for SDTM, ADaM and FDA electronic data submission requirements
- Advanced knowledge with FDA and ICH regulations and guidelines, medical terminology and clinical trial methodologies
- Good communication skills
- SAS server-based knowledge.