Statistical Programming Manager

Manager- Statistical Programming

Job description:

Anywhere in India/Remote

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.

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.

• Work within a company with a solid track record of success
• Work alongside & learn from best in class talent
• Join a well known brand within Hospital / Health Care / Healthtech