Job Description
Location - Bengaluru
Exp - 12-14 Years
Requirements :
To succeed in this role, you’ll be an experienced programmer with good knowledge of technical and regulatory requirements related to programming within the pharmaceutical or healthcare industry. You’ll enjoy multitasking, have an appetite for solving problems with a strong team focus who enjoys collaborating to achieve the best results.
What You'll Do
The Associate Director Statistical Programming is accountable for leading, managing and developing a team of programmers. They present a delivery/department mindset and management skills to run and oversee one moderate scope and complexity drug project or multiple smaller ones. As a recognized expert within their own field they are often the first point of contact for related queries, acts as a coach or mentor for staff, and acts as a specialist within cross-functional teams to deliver continuous improvement.
You will work in the Programming department that not only oversees and delivers the programming aspects of analysis and reporting but also manages and maintains our end-to-end standards and our analysis and reporting production tools. You’ll be part of a global team that pulls together to put patients first.
• Leads, manages and develops a group of programmers, providing guidance and mentorship. Manages training and timesheet compliance
• Work according to agreed functional and regional SHE strategy by ensuring proper management of SHE risks, incidents, reporting, follow-up and improvements.
• Arranges and structures the team in order to create an environment where the team can work productively and collaboratively together
• Defines, monitor and assess objectives for team
• Provides input to capacity management for all projects in scope
• Captures business needs and plans recruitment accordingly
• Recruits and builds the team with the appropriate skill set
• Maintains talent and ensures talent development
• Maintains own and team knowledge of the latest industry and regulatory requirements to stay current in the Programming practices
• Leads Implementation of statistical programming aspects of the of the protocol or clinical development program
• Acts as technical subject matter expert for aspect(s) of the TA, Project, or function
• Manages activities of our external partners (i.e. Contract Research Organisations)
• Accountable for managing contracting staff
• Manages and escalate risk in complicated or novel situations within their study and/or projects
• Overall accountability for the quality and compliance to internal, external and regulatory requirements for the delivery of programming aspects in clinical development; holds partners and providers accountable for the quality of their deliverables
• Leads or participates in cross-functional administrative or process improvement initiative(s)
• Drives the continuous improvement of the team and function through personal action and process initiatives
• Drives the development of best practices to improve quality, efficiency and/or effectiveness within function
• Contributes to the function by providing training and mentorship
• Influences stakeholders by providing subject matter expertise on programming related items
• Drives standards development and implementation
• Measures the compliance of and ensures that there is a consistent approach to data standards and automation and its implementation
• Collaborates/influence cross-functionally and represents Programming leadership where required
• Lead or Manage Statistical programming deliverables for Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Investigators brochures (IB)
Essential for the Role:
• BSc in Mathematical (i.e., Applied Math, Engineering, etc.), Statistical, Computer Science or Life Science.
• Extensive SAS programming expertise to an advanced level
• Comprehensive knowledge of technical and regulatory requirements related to the role.
• Knowledge of CDSIC standards and industry best practices
• Extensive experience in clinical drug development or healthcare
• Experience in Regulatory submissions.
• Excellent verbal and written communication skills and influence stakeholders.
• Travel – willingness and ability to travel domestically and/or internationally.
• Ability to apply programming knowledge and skills to problems, problem solving, and quality focus.
• Contributes to defining business processes and accurately completes and manages associated documentation.
• Team commitment: prioritize attendance at appropriate project team meetings; take steps to understand and appreciate the roles, skills and strengths of others on the team.
• Diligence – attention to detail and ability to manage concurrent projects and activities within those projects.
Desirable for the Role
• Other programming languages e.g. S-PLUS, R, XML etc.
• Extensive knowledge of Open CDISC Validator
Interested candidates can send there updated cv on shubham.g@domniclewis.com or Call on 836+05475+
Exp - 12-14 Years
Requirements :
To succeed in this role, you’ll be an experienced programmer with good knowledge of technical and regulatory requirements related to programming within the pharmaceutical or healthcare industry. You’ll enjoy multitasking, have an appetite for solving problems with a strong team focus who enjoys collaborating to achieve the best results.
What You'll Do
The Associate Director Statistical Programming is accountable for leading, managing and developing a team of programmers. They present a delivery/department mindset and management skills to run and oversee one moderate scope and complexity drug project or multiple smaller ones. As a recognized expert within their own field they are often the first point of contact for related queries, acts as a coach or mentor for staff, and acts as a specialist within cross-functional teams to deliver continuous improvement.
You will work in the Programming department that not only oversees and delivers the programming aspects of analysis and reporting but also manages and maintains our end-to-end standards and our analysis and reporting production tools. You’ll be part of a global team that pulls together to put patients first.
• Leads, manages and develops a group of programmers, providing guidance and mentorship. Manages training and timesheet compliance
• Work according to agreed functional and regional SHE strategy by ensuring proper management of SHE risks, incidents, reporting, follow-up and improvements.
• Arranges and structures the team in order to create an environment where the team can work productively and collaboratively together
• Defines, monitor and assess objectives for team
• Provides input to capacity management for all projects in scope
• Captures business needs and plans recruitment accordingly
• Recruits and builds the team with the appropriate skill set
• Maintains talent and ensures talent development
• Maintains own and team knowledge of the latest industry and regulatory requirements to stay current in the Programming practices
• Leads Implementation of statistical programming aspects of the of the protocol or clinical development program
• Acts as technical subject matter expert for aspect(s) of the TA, Project, or function
• Manages activities of our external partners (i.e. Contract Research Organisations)
• Accountable for managing contracting staff
• Manages and escalate risk in complicated or novel situations within their study and/or projects
• Overall accountability for the quality and compliance to internal, external and regulatory requirements for the delivery of programming aspects in clinical development; holds partners and providers accountable for the quality of their deliverables
• Leads or participates in cross-functional administrative or process improvement initiative(s)
• Drives the continuous improvement of the team and function through personal action and process initiatives
• Drives the development of best practices to improve quality, efficiency and/or effectiveness within function
• Contributes to the function by providing training and mentorship
• Influences stakeholders by providing subject matter expertise on programming related items
• Drives standards development and implementation
• Measures the compliance of and ensures that there is a consistent approach to data standards and automation and its implementation
• Collaborates/influence cross-functionally and represents Programming leadership where required
• Lead or Manage Statistical programming deliverables for Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Investigators brochures (IB)
Essential for the Role:
• BSc in Mathematical (i.e., Applied Math, Engineering, etc.), Statistical, Computer Science or Life Science.
• Extensive SAS programming expertise to an advanced level
• Comprehensive knowledge of technical and regulatory requirements related to the role.
• Knowledge of CDSIC standards and industry best practices
• Extensive experience in clinical drug development or healthcare
• Experience in Regulatory submissions.
• Excellent verbal and written communication skills and influence stakeholders.
• Travel – willingness and ability to travel domestically and/or internationally.
• Ability to apply programming knowledge and skills to problems, problem solving, and quality focus.
• Contributes to defining business processes and accurately completes and manages associated documentation.
• Team commitment: prioritize attendance at appropriate project team meetings; take steps to understand and appreciate the roles, skills and strengths of others on the team.
• Diligence – attention to detail and ability to manage concurrent projects and activities within those projects.
Desirable for the Role
• Other programming languages e.g. S-PLUS, R, XML etc.
• Extensive knowledge of Open CDISC Validator
Interested candidates can send there updated cv on shubham.g@domniclewis.com or Call on 836+05475+
💡 Quick Summary
Seeking a career-building opportunity? The Senior Statistical Programmer position is now open for candidates interested in the Software Developer Jobs sector. This role in Bengaluru offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Software Developer Jobs is a plus.