Senior Analyst - Clinical Data Management

Work Flexibility: Hybrid or Onsite

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Staff Biostatistician to join our Neurovascular division to be located in Gurgaon, Haryana.

Stryker’s Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include: stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters. In February 2019, Stryker Corporation (NYSE:SYK) announced that for the ninth consecutive year has been named as one of the 2016 FORTUNE 100 Best Companies to Work For ranking 11 out of 100. If you join our organization; will be working to “Make Stroke History”. Stroke is devastating; 1 of 20 deaths is from a stroke, according to the CDC. Watch this video to see how Stryker is making a difference: https://www.youtube.com/watch?v=JANFZrpt1Hg.

Who we want

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate. 
• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. 
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. 
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. 

• Qualifications and Experience

  
  
• 6 to 12 years of relevant experience
• Experience in Medical Devices preferred.

• Pharmacy, Nursing or Medical Graduation, Post graduation preferred

  
  
• Any Graduation with Clinical Research post-graduation
• Knowledge of clinical trial design and analysis preferred.
• Knowledge of regulatory guidelines (FDA/CFR; ISO14155) preferred.
• Experience supporting publication of analysis results (e.g. abstracts, posters, manuscripts) preferred.
• Experienced with electronic data capture (EDC) system(s) preferred.
• Excellent in both oral and written communications. 
• Ability to explain basic statistical concepts to non-statisticians.
• Good organizational and time management skills.

What you will do

1. Data Review and Data Medical Review

a. Identifying data related discrepancies such as missing data, potentially discrepant and mismatching data with other fields

b. Identifying the potential data discrepancies from medical and clinical perspective

c. Medical and Product Coding, collaborate with Medical Sciences for coding review and approval.

2.

Data Querying and Integrity Management

a. Lead the data querying and completion process during data review

b. Generate data discrepancy criteria and associated queries on the data review

c. Develop and periodically publish data entry metrics and work closely with the Clinical Study Manager (CSM) to allocate resources based on priorities.

d. Analyze the data by fields and identify trends and pattern to detect suspicious data activities

3. Data cleaning

a. Taking requisite actions on the non-standard data Identified in data review process

b. Coordinating with the CRAs for getting the data completed, corrected and confirming the extreme or outlier values

c. Develop complex status reports and utilize status reports to determine follow-up action.

4. Base Data Management Process

a. Coordinate Case Report Form (CRF) development, review and approve final CRFs.

b. Review and approve data entry screen shots during database development
processes.

c. Design and/or participate in design of data management documentation and SOPs.

d. Participate in preparation and presentation of data management activities and new initiatives.

e. Review SAS program specifications and perform UAT when appropriate.
f. Write or review a DMP (Data Management Plan) for a specific project or program.

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