Principal Statistical Programmer

Description

Kenvue 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 Kenvue , 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 brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers.

With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day.

We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant 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 all 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 ad hoc/ post hoc analysis.

• The incumbent will work closely with biostatistics, data management, clinical research, regulatory affairs, and external functional service providers to ensure all 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 make a meaningful impact.

Key Responsibilities

• Provides expert support and direction in statistical programming design to ensure timely and accurate reporting for assigned projects and ad hoc requests.

• Manage programming activities for clinical studies, including activities related to data management, statistical analysis, and reporting.

• Ensure all SAS Programming activities are conducted in accordance with high ethical and quality standards, GCP regulations, and company procedures.

• Oversee 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.

• Develop and manage specifications for Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets, as well as data submission package preparation.

• Develop, 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.

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