Years of Experience: 15+ years
Skill Set / Exposure: Programming Background, SAS, R, CDISC Standards, Clinical study, Line management, Project leadership and Clinical/Regulatory Submission.
Work Location: Bengaluru
Job Description:
Technical Expertise, Scientific Leadership and Strategy:
- Leads, or makes a major contribution to, the planning and execution of multiple programming activities to deliver required outputs within Disease area.
- Provide leadership of technical expertise across assigned DA portfolio, ensuring high quality study data delivery.
- Act as a subject matter expert within own discipline and provide technical guidance to complex tasks.
- Have good knowledge and awareness of leading edge statistical/programming methods and standards used in industry.
- May take Project Programmer role for complex portfolio and take accountability for clinical programming deliverables of a clinical asset.
- Should be able to manage and develop project level roles like project programmer/indication programmer/Study level key roles.
- Initiate new directions and novel strategies to achieve Biostatistics (India) department and Disease area objectives.
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.
- Proficiency in R and experience in other programming languages, such as SAS, Python, etc.
- 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 (SDTM, ADaM) 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.
- Very effective written, and verbal communication skills.
Preferred Qualifications & Skills:
- 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).
- Skilled in graphics, data wrangling/engineering.
- Ability to effectively multi-task and work on one or more deliverables during a sprint.
- 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.
Innovation, Problem Solving and Decision Making:
- Provide creative solutions to deal with team level challenges; suggest and drive innovative solutions to achieve upper quartile performance in assigned portfolio.
- Regularly deal with resourcing and project management related challenges within their disease area.
- Support and empower managers in making study/project level decisions as relevant.
- Work independently and liaise with Programming Head to ensure effective co-ordination of activities, delivery of Biostatistics (India) objectives and the escalation/resolution of complex issues, as required.
- As a leader and member of the global LT, effectively support the Head of Programming, India and Global DA/RU/RDC Programming Heads, by providing strategic and tactical inputs as needed.
- Actively engage in risk management evaluation to identify effective risk management strategies for the mitigation of known and anticipated risks. Assure communication and escalation of risk solutions.
- Proactively recommend new or more efficient ways of working.
Compliance, Quality & Governance:
- Ensure high quality deliverables from Biostatistics (India) assigned Disease area programming team lead after action reviews, share learnings and implement solutions as needed.
- Understand how GSK policies and procedures impact projects and be fully compliant in implementation.
- Contribute to the development or improvement of departmental policies and working practices.
- Lead or coordinate response to audit/inspection questions, implement agreed Corrective and Preventative Actions (CAPAs) and support effective sharing of learnings across the department.
- Identify and address issues with assigned activities and works to develop solutions with internal teams and/or outsourced partners.
Communication and Influence:
- Independently, prepare detailed oral or written summaries in the context of strategic fit, feasibility and rationale for projects appropriate to audience.
- Be an effective communicator by adopting a range of communication styles based on situation and/or audience. Support and develop others by acting as a coach or mentor.
- May represent GSK at external professional/ industry organization meetings and work on industry-wide issues (e.g., ICH working group, CDISC).
Collaboration and Matrix-Working:
- Work effectively and proactively in multi-disciplinary teams and a matrix environment through effective listening and active participation in challenging discussions.
- Exert influence within cross-functional teams across the organization.
- Independently build and maintain effective relationships across departments, functional lines and outsourced partners.
- Knowledgeable about working styles of different relevant LTs and their members and influence them as needed.
- Be a strategic partner to global disease area head and contribute to project management and resourcing in global projects.
Leadership and People Development:
- Provide leadership to programming team of 8+ in a Disease area ensuring high quality and compliance.
- Strategize in developing key roles and execution of critical/pivotal tasks with full ownership and accountability.
- Lead or significantly contribute to capability project initiatives (e.g. Technical Trainings, RAPIDO, SPACE etc.)
- Effectively engage 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.
- Lead recruitment activities to hire talented programmers/statisticians to meet targets as outlined in hiring plan and maintain a keen focus on staff engagement activities to limit attrition.
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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