Skill Set / Exposure: Clinical Programming Background, Line management, SAS, R, CDISC Standards (ADAM & TFL’s), Clinical study, Project leadership, Cross functional stakeholder management and Matrix Management.
Work Location: Bengaluru
Clinical Programming at GSK:
- GSK Clinical Programming brings together some of the most talented minds to engage in advanced data analytics, principles of data science, and developing new computational tools to support innovative research and develop novel therapies.
- We serve five key therapeutic areas: HIV, Immunology, Infections Disease, Oncology, Respiratory, and Vaccines, and offer unlimited growth opportunities and exciting career paths for a wide range of experience levels.
Responsibilities:
- The Associate Director/Programming Leader role at GSK reports into the disease area head and are expected to perform all project programmer/programming leader responsibilities for one or multiple projects.
- They may have people management responsibilities.
- Associate Directors/Programming Leaders are not expected to engage in hands-on programming activities; however, they are expected to be the main point of contact for any technical questions from their programming or wider study teams.
- They are the single point accountable person on study related decisions, such as timelines, resourcing, programming’s contributions, etc.
- They represent programming in clinical matrix and other cross functional meetings and setting the direction of their study and team (with or without senior level supervision).
- They possess strong problem-solving skills, and are confident communicators, and influencers.
- Associate Directors/Programming Leaders lead the planning, prioritization, and execution of multiple clinical trial programming activities and projects.
- This may include, but is not limited to, approval of plans, developing timelines, identifying resources, defining expectations with non-programming study team members, and creating, verifying, and documenting analyses of clinical data while adhering to study protocols, analysis plans and GSK / industry standards.
- They may have direct line management responsibilities.
- They are expected to strategically identify future gaps and develop resolution plans across the disease area and possibly the therapeutic area.
- Associate Directors/Programming Leaders initiate or lead capabilities and non-project initiatives, present at internal and external forums, and mentor team members on technical and leadership skills. They also represent programming amongst their non-programming peers.
- Acts as technical expert both internally and externally.
- Acts as an expert representing programming function on departmental and cross-departmental initiatives providing input and influencing groups outside of own discipline.
- Negotiates strategy and issues at internal regulatory meetings.
- Effectively explains concepts at all levels in the organization, including senior managers/stakeholders.
- Defines, develops, and embeds standards / best practices within the programming function in accordance with internal and industry standards.
- Represents programming at external discussions of technical concepts and use of standards, to advance technical capability across the industry.
- Independently explores options to assess the efficiency and impact of different approaches on work activities and effectively communicates these aspects to the broader matrix team.
- Manages change or capability improvement initiative to introduce new technology to increase efficiency or simplification within own function.
- Consistently contributes to solving problems and proactively considers how solutions could be applied more broadly ensuring knowledge can be captured and reused.
- Promotes new innovations and efficient ways of working.
- Leads teams providing innovative solutions to solve highly technical problems and drive efficiencies.
- Makes decisions on the implementation of programming requirements.
- Takes accountability for quality of deliverables within own and teams’ work and flags emerging compliance, quality, or data integrity issues.
- Leads, or makes major contributions to, the development or revision of internal policy, guidance, standards, technical compliance related documentation, process improvement, and/or data integrity initiatives.
- Leads or coordinates response to audit/inspection questions, implement agreed CAPAs and support effective sharing of learnings across the department.
- Provides review and comments on external draft regulatory or other industry-wide proposals.
- Effectively defines, provides oversight, and manages scope and delivery of outsourced activities to third parties, and where relevant acts as the Business Owner and/or Technical Approver
- Proactively anticipates issues and develops solutions using appropriate escalation routes with internal teams and/or outsourced partners.
- Demonstrates effective listening/communication skills to influence colleagues and stakeholders at a project, matrix and/or department level.
- Demonstrates communication and influencing skills with key external experts/stakeholders (such as consultants, therapeutic area experts and regulators) and outsourced partners.
- Effectively communicates GSK standard processes and best practices to outsourced partners.
- Provides programming leadership and work effectively in a multi-disciplinary team to make significant contributions to achieve project/program milestones.
- Effectively coordinates and leads internal and external collaborations.
- Acts as a mentor and/or coach and facilitates knowledge and skill development of team members.
- Allocates decision-making authority and task responsibilities to appropriate direct reports / team members, utilizing time, skills, and potential effectively.
- Identifies skills, strengths, competency gaps, and development needs of staff and team.
- Empowers staff in career development discussions.
- Proactively supports development, working with individuals to set stretched goals aligned to business need and plans/creates development opportunities.
- Proactively encourages and drives staff to take on new areas, especially innovation.
- Tracks and evaluates performance and development; give timely and constructive feedback.
- Effectively engages with GSK’s formal Talent Management and Succession Planning processes; identify and develop talent to have the right skills, capabilities, and experiences to match future business needs.
- Leads or inputs into resource management and recruitment activities.
Qualifications & Skills:
- A BSC, BA or equivalent in Mathematics, Statistics, Computer Science or related subject.
- Statistical programming and leadership experience in clinical R&D is required.
- Advanced proficiency in one or more programming languages, such as R, Python, and/or SAS.
- Experience with using other clinical data analysis and reporting tools, such as Spotfire, SAS Azure, or S-Plus.
- Advanced macro development and debugging and executing complex programming activities skills.
- Knowledge of standard macro development process.
- Strong expertise in CDISC standards and its application.
- Strong knowledge of Good Practice (GxP), and International Council for Harmonization (ICH) requirements.
- Knowledge of Microsoft Office software (MS Word, Excel, PowerPoint, Outlook).
- Expertise with submission activities and related documentation.
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
- MSc or PhD (or equivalent) in Mathematics, Statistics, Computer Science or related subject preferred.
- Solid understanding of the pharmaceutical regulatory and publishing processes (e.g., 21 CFR Part 11).
- Advanced expertise in end-to-end clinical trial process and application of key clinical documents.
- Expertise in therapeutic area specific requirements.
- Very effective written, and verbal communication skills.
- Experience with mentoring and supervising junior programmers on technical tools and concepts.
- Experience with outsourcing of statistical programming work in the clinical trials setting (e.g., working with CROs, academic institutions, etc.).
- Expertise in representing programming function in cross-functional meetings, initiatives, and working group.
- Strong interest in or experience contributing to external organizations (e.g., PHUSE, PharmaSUG, etc.)
- Experience with working within a global team and managing expectations across different time zones.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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