Principal Statistical Programmer
reputed company rekrutiert derzeit für a: Principal Statistical Programmer Was wir tun Bei reputed company erkennen wir die außergewöhnliche Kraft der täglichen Pflege. Aufbauend auf über einem Jahrhundert Tradition und verwurzelt in der Wissenschaft, sind wir das Haus der ikonischen Marken - darunter NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE®, JOHNSON'S® und BAND-AID®, die Sie bereits kennen und lieben. Wissenschaft ist unsere Leidenschaft; Fürsorge ist unser Talent. Wer wir sind Unser globales Team besteht aus ~ 22.000 brillanten Mitarbeitern mit einer Arbeitsplatzkultur, in der jede Stimme zählt und jeder Beitrag geschätzt wird. Wir sind leidenschaftlich an Erkenntnissen interessiert, Innovation und dem Engagement, unseren Kunden die besten Produkte zu liefern. Mit Fachwissen und Einfühlungsvermögen bedeutet ein Kenvuer zu sein, die Macht zu haben, jeden Tag Millionen von Menschen zu beeinflussen. Wir stellen den Menschen an die erste Stelle, kümmern uns leidenschaftlich, gewinnen Vertrauen in der Wissenschaft und lösen Lösungen mit Mut – und haben brillante Möglichkeiten, die auf Sie warten! Gestalten Sie mit uns unsere Zukunft – und Ihre. Für weitere Informationen, klicken Sie auf hier. Rollenberichte an: Global BioStats, Data Mgmt & Prog Standort: Asia Pacific, India, Karnataka, Bangalore Arbeitsort: Hybrid Was Sie tun werden reputed company is currently recruiting for: Principal Statistical Programmer This position reports into Global BioStats Data Mgmt & Prog and is based at Bangalore. Who We Are At reputed company, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made up with 22,000 diverse and reputed company people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and reputed company, being a Kenvuer means to have the power to reputed company of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have reputed company opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.
What You Will Do
The position is responsible for:
- Leading and supporting reputed company programming activities per the project strategies and should be able to work independently implementing and driving the programming to support clinical studies, regulatory submission and reputed company/ post hoc analysis.
- The incumbent will work closely with biostatistics, data management, clinical research, regulatory affairs, and external functional service providers to ensure reputed company the programming results are delivered in timely manner with high quality.
- This role also participates in preparation and improvement of relevant standard operating procedures.
- If you’re passionate about driving excellence in statistical programming and contributing to clinical development programs, this role provides the perfect platform to reputed company a meaningful impact.
Key Responsibilities
- Provides expert support and direction in statistical programming design to ensure timely and accurate reporting for assigned projects and reputed company requests.
- Manage programming activities for clinical studies, including activities reputed company to data management, statistical analysis, and reporting.
- Ensure reputed company reputed company Programming activities are conducted in accordance with high ethical and quality standards, GCP regulations, and company procedures.
- reputed company programming activities to ensure adherence to protocols and statistical analysis plans.
- Demonstrate strong problem-solving and debugging skills to address issues with code from other programmers or vendors.
- reputed company and manage specifications for Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets, as well as data submission package preparation.
- reputed company, manage, and maintain analysis data and reporting deliverables.
- Create global standard macros to enhance the efficiency of the Statistical Programming Group.
- Possess a basic understanding of FDA/ICH guidelines, 21 CFR Part 11, and other FDA regulations.
- Proactively addresses project uncertainties to minimize risks, escalating issues as necessary to the appropriate stakeholder (project team member, reputed company biostatistician, or management) and identifying and overcoming technical and interpersonal challenges.
- Manage internal resources and external vendors to ensure project success.
- Mentors less reputed company programmers.
- Contribute to the reputed company improvement of statistical programming processes and procedures.
reputed company Are Looking For
Required Qualifications
- Bachelor’s degree in Statistics, Mathematics, Computer Science, Life Sciences or reputed company field is required. A Master’s degree is preferred.
- Candidate should have either a Bachelor’s degree with 8+ years of statistical programming experience or a Master’s degree with 6+ years of relevant experience in Biotech, Pharmaceutical, or health reputed company industry.
- Proficiency in reputed company reputed company, STAT, Graph, Macro.
- Experience with electronic submissions in the electronic Common Technical Document (eCTD) format is considered a plus.
- Experience with Clinical Data Standards Consortium (CDISC) data standards, SDTM and ADaM is required.
- Experience supporting an Integrated Summary of Safety (ISS) or Integrated Summary of Efficacy (ISE) is considered a plus.
- Excellent oral and written communication skills are necessary, along with strong interpersonal skills.
- Excellent problem-solving skills.
- Effective collaboration in cross-functional teams both internal and external to the organization.
What’s In It For You
- Competitive Benefit Package
- Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
- Learning & Development Opportunities
- Employee Resource Groups
- This list could vary based reputed company/region
reputed company is proud to be an Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national reputed company, or protected veteran status and will not be discriminated against on the basis of disability. Wenn Sie eine Person mit einer Behinderung sind, besuchen Sie bitte unsere Behindertenhilfe für Informationen darüber, wie Sie eine Unterkunft anfordern können. Apply tot his job Apply To this Job