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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.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in programming practices and regulatory guidelines, with a strong focus on project management and team leadership in the clinical research domain. Proficient in data manipulation and reporting using relevant programming languages, ensuring compliance and quality in deliverables.
Highest-signal resume keywords
People Management ExperienceExpert CDISC Standards KnowledgeSAS Programming ProficiencyProject Management SkillsRegulatory Guidelines Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
SASRPythonProgramming PracticesData ManipulationReportingProject ManagementRisk ManagementTeam ManagementClinical Trials Experience
Soft Skills
Excellent Communication SkillsInfluencing SkillsNegotiation SkillsPlanning and CoordinationCollaboration
Industry Keywords
PharmaceuticalCROBiotechICH-GCP21 CFR Part 11Clinical ResearchOutsourcingStakeholder ManagementMatrix EnvironmentProcess Improvement
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