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Principal Statistical Programming Lead
Johnson & JohnsonPrincipal Statistical Programming Lead at Johnson & Johnson in India. Developing solutions for complex clinical research analysis and reporting, leading programming teams and ensuring deliverable quality.
Tech Stack
Tools & technologiesGoogle Cloud PlatformPython
About the role
Key responsibilities & impact- Designs and develops efficient programs and technical solutions in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis requests.
- Provides technical and project specific guidance to programming team members to ensure high quality and on-time deliverables in compliance with departmental processes.
- Coordinates and oversees programming team activities and may provide matrix leadership to one or more programming teams as needed.
- Shares knowledge and provides guidance and coaching to programmers in developing advanced technical and analytical abilities.
- Performs comprehensive review of, and provides input into, project requirements and documentation.
- Collaborates effectively with programming and cross-functional team members and counterparts to achieve project goals and independently manages escalations.
- As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality.
- Responsible for adoption of new processes & technology on assigned projects/programs in collaboration with departmental technical groups and programming portfolio leads.
- Contributes to and may lead departmental innovation and process improvement projects and may contribute programming expertise to cross functional projects/initiatives. May play the role of a Delivery Unit/Disease Area Expert.
- Ensures continued compliance of project/programs and required company and departmental training, time reporting, and other business/operational processes as required for position.
Requirements
What you’ll need- Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth).
- Approx. 6+ years of experience (as principal/portfolio lead) in Pharmaceutical, CRO or Biotech industry or related field or industry.
- People management experience is mandatory.
- In-depth knowledge of programming practices (including tools and processes).
- Working knowledge of relevant regulatory guidelines (e.g., ICH-GCP, 21 CFR Part 11)
- Project, risk, and team management and an established track record leading teams to successful outcomes.
- Excellent planning and coordination of project delivery.
- Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors.
- Experience managing the outsourcing or externalization of programming activities in the clinical trials setting (e.g., Working with CROs, academic institutions) preferred experience.
- Expert CDISC Standards knowledge.
- Expert knowledge of relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required for a Clinical Programming role.
- Excellent written and verbal communications and influencing and negotiation skills.
Benefits
Comp & perks- Inclusive work environment
- Training compliance and development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
SASRPythonProgramming PracticesData ManipulationReportingProject ManagementRisk ManagementTeam ManagementClinical Trials Experience
Soft Skills
Excellent Communication SkillsInfluencing SkillsNegotiation SkillsPlanning and CoordinationCollaboration