Manager of Statistical Programming

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

• Program 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 the above job duties, the 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 CONFORM eClinical modules.
• Works with the IT department to set up and ensure a secure environment with proper access control on SAS servers.
• Works with the product development team on the enhancement of the CONFORM platform and process automation.
• Works with the Quality Assurance team on Standard Operating Procedures drafting and revision, as well as testing and validation of CONFORM modules.
• Mentor and review the performance of members.

MSP reports to the Senior Manager of Statistical Programming or the Director, Data Management and Statistical Programming.

QUALIFICATION FOR ESSENTIAL FUNCTIONS

1. Ability to communicate effectively in English, in both writing and verbal.

2. Ability to learn quickly and pay attention to details.

3. Ability to manage multiple tasks/projects, effectively prioritize and execute tasks, and make quality and on-time deliveries.

4. Ability to work collaboratively, effectively, and productively in diverse organizational structures, and in

interaction with dynamic clients.

1. Ability to work independently, takes ownership and strives for quality and efficiency.

2. Ability to work positively in a continually changing environment.

3. 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

1. Master's degree in statistics or related fields with 8+ years of industry experiences as a Statistician

2. PhD degree with 5+ years of postgraduate experiences in Biostatistics or equivalent.

3. Prior experience of leading Biostatistics team.

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.
• The 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.