Statistical Programming Associate Manager

• This role reports to the Director of Statistical Programming.
• This role will cover the Principle Statistical Programmer Role, Team Management, and Project Management
• Have overall accountability for the efficient quality delivery, utilization, and team development within the programming department, liaison between the US and project delivery team for the assigned client engagement or projects.
• Ensure the programming team is delivering the projects on time, quality, and budget.
• Support developing staff competencies for consistent team development and aligned staff remuneration of the subordinate team member in collaboration with the Director of Statistical Programming.
• Ensure process improvement and knowledge-sharing is in place across the programming department.
• Manage the efficient resource allocation within the programming team for various projects, clients based on the requirements. Manage the Ad-Hoc request on-demand.
• Collaborate with Department Head for effective goal setting for the team.
• Ensure timely review of team performance quarterly and perform the final year appraisal for the team and share the recommended rating for staffs
• Ensure the effectiveness of the graduate training programs.
• Conduct meetings with statisticians and programmers for business needs.
• Coordinate client activities related to the projects. Represent the Programming Department during internal and external audits.
• Develop and implement standard operating procedures for programming operations.
• Innovative and be able to take initiatives and follow through in programming workflow optimization.
• Support the Business Development team for new client projects, RFPs, etc.
• Support the programming staff’s recruitment, retention, and recognition in collaboration with the internal TA team and HR.

Secondary Responsibilities:

• Align with deliverables and project metrics as per client SLA and/or as per internal metric parameters [examples: timelines, quality, etc.]
• Responsible to ensure training compliance and timesheet compliance
• Be aware of and comply with the QMS/ ISMS & PIMS Policy.
• Report any potential or actual Security Breaches to the regional and/or global DPO & Security Incidents to CISO/ applicable distribution list.
• Contribute towards the achievement of Quality Objectives

Qualifications:

• Bachelor’s degree or equivalent required, preferably in life science, statistics, computer science, or related subjects.
• Should have a minimum of 4+ years of experience within the pharmaceutical industry with 2+ years of management experience.
• Extensive experience within the pharmaceutical industry with clinical programming and clinical development processes across major therapeutic areas.
• Good knowledge and experience in study setups, different processes, tasks such as SDTM, SDRG, ADaM, ADRG, TFL, ISS/ISE, Define XML, ISO Listings, Macro Programming, etc. and analysis the requirements for clinical programming projects.
• In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology, e.g., ICH-GxP, E3, E6, etc.
• Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.
• Excellent written and verbal communication skills, negotiations, collaborations, and interpersonal skills. Excellent problem and conflict resolution skills