Manager, Statistical Programming

Reposted 21 Days Ago
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Chennai, Tamil Nadu
In-Office
Senior level
Other
The Role
The Manager of Statistical Programming oversees statistical programming for client projects, manages staff, implements strategies for productivity and quality, and ensures adherence to regulatory guidelines.
Summary Generated by Built In

Job Description:

Manager, Statistical Programming

The Manager, Statistical Programming is responsible for the statistical programming aspects of projects for clients and project teams through management of internal staff and for maintaining optimal department processes, implementing project-specific strategies, and assisting with the development and implementation of department strategies to increase productivity and quality, while decreasing cycle times and costs.

Make an Impact at Veristat!

Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.

  • 105+ approved therapies for marketing applications prepared by Veristat
  • 480+ oncology projects in the past 5 years
  • 350+ rare disease projects delivered in the past 5 years
  • Flexible, inclusive culture — 70% remote workforce, 66% women-led teams
  • Learn more about our core values here!

What we look for:

• Master’s degree in technology, statistics, pharmaceutics or another related science or mathematics field with a minimum of 5 years of SAS programming experience with clinical trial data using CDISC SDTM and ADaM implementation guidelines OR Bachelor’s with a minimum of 8 years of SAS programming experience with clinical trial data using CDISC SDTM and ADaM implementation guidelines.

• 3 years of supervisory OR 5 years of project lead experience in a CRO required.

• Excellent working knowledge of CDISC SDTM and ADaM Implementation Guidelines.

• Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.

• Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical and biotech companies.

• Excellent knowledge of regulatory requirements and drug development process.

• Excellent organizational skills and verbal/written communication skills.

• Strong communication skill set with peers, business partners, and Sponsors.

• Strong analytical mindset.

Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.

#LI-SI1

Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Top Skills

Adam
Cdisc Sdtm
SAS
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The Company
Basel
443 Employees

What We Do

Veristat is the science-first full-service drug and biologic CRO and consultancy that integrates strategic planning, regulatory expertise, and clinical trial execution to rapidly advance the most complex or novel therapies.

At Veristat, we collaborate with clients to support the rapid delivery of life-changing therapies, helping them make sound decisions amidst uncertainties. Our scientific experts design and conduct the global activities required for any clinical, regulatory, or commercialization program comprehensively and efficiently. ​

With our focus on novel drug development and nearly 30 years of experience, our versatile approach and bold scientific thinking make the impossible possible. Depend on our game-changing expertise and reliable execution for fast results and positive impact to support your biologics and drugs to treat rare cancers, CNS/Neurological disorders, Endocrine/metabolic disorders, and infectious diseases.

We are…Bold. Scientific. Versatile. Veristat.​

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Veristat has recently been made aware that unknown third parties that have no connection to Veristat are generating fake Veristat job postings, interviews, and even fake employment offers via emails, websites, and various social media platforms, seemingly for the purpose of fraudulently obtaining personal information from legitimate job candidates. All legitimate correspondence from Veristat will originate from our applicant tracking system (Jobvite) or an @veristat.com email address. If you have received outreach from someone claiming to be a member of our team please search our official LinkedIn company page (https://www.linkedin.com/company/veristat-llc), where all members of our authorized recruiting team can be identified, or contact us directly at [email protected]. Be vigilant

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