Job Description
JOB DESCRIPTION
The Manager of Statistical Programming (MSP) will stay hands-on with daily activities of a Statistical Programmer I (SP I) or Statistical Programmer II (SP II). He/she
- Programs all tables, listings and graphs necessary for an assigned clinical study report (CSR);
- Acts as lead programmer for assigned projects;
- Programs customized data displays, (including data listings, summary tables and routine graphics) in accordance with the approved statistical analysis plan (SAP) and shell displays for clinical research studies;
- Writes code using Base SAS programs, SAS procedures, or standardized macros;
- Analyzes protocol, SAP, existing shells/templates as needed to understand structure and content of data;
- Performs data checks as needed, to ensure integrity and correctness of data displays;
- Prepares documentation for programs;
- Prepares documentation describing all datasets and variables within, including derived variables, and the project as a whole;
- Creates SAS datasets of clinical data from clinical databases;
- Creates status and efficacy datasets;
- Creates project-specific macros and formats;
- Loads client data from other platforms and other software packages;
- Prepares data to be sent to clients and as needed for other external transfers and data imports.
- Review the SAP and TLF mock-ups from programming’s perspective.
- In addition to above job duties, Manager of Statistical Programming also
- Communicates with clients to set and manage project timelines and deliverables;
- Assigns projects to the team and solves problems and/or technical difficulties;
- Trains junior team members on industry regulations, standards and internal tools used;
- Trains clients on internal eClinical modules;
- Works with IT department to setup and ensure a secure environment with proper access control on SAS servers;
- Collaborates with product team on platform enhancements and process automation;
- Works with Quality Assurance team on Standard Operation Procedures drafting and revision, as well as supports testing and validation of internal data management modules.
- Mentor and review the performance of members
- MSP reports to Senior Manager of Statistical Programming or Director, Data Management and Statistical Programming.
WORK REQUIREMENTS
1. Corporate office environment.
2. Some travel (5%) may be required with a potential of travel occurring over weekends.
3. Cross-functional interactions
TRAINING
- Complete Training Requirements per current Training Requirements List.
- Supervisor will assign additional skills training, one-on-one, see-one / do one, or other Training as necessary to achieve qualifications and improve job performance.
Ideal Profile
QUALIFICATION FOR ESSENTIAL FUNCTIONS
- Ability to communicate effectively in English, in both writing and verbal.
- Ability to learn quickly and pay attention to details.
- Ability to manage multiple tasks/projects, effectively prioritize and execute tasks, and make quality and on time deliveries.
- Ability to work collaboratively, effectively, and productively in diverse organizational structures, and in interaction with dynamic clients.
- Ability to work independently, takes ownership and strives for quality and efficiency.
- Ability to work positively in a continually changing environment.
- Solid/Advanced SAS skills and understanding of the concept of standardization in data, programming, and statistical reporting of trial results and its implication to drug development.
EDUCATION AND EXPERIENCE REQUIRED
- Master’s degree in statistics or related fields with 8+ years of industry experiences as a Statistician
- PhD degree with 5+ years of postgraduate experiences in Biostatistics or equivalent.
- Prior experience of leading Biostatistics team.
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