ClinChoice Logo

ClinChoice

Manager, Statistical Programming Consultant

Reposted 6 Hours Ago
Be an Early Applicant
Remote
Hiring Remotely in United States
Senior level
Remote
Hiring Remotely in United States
Senior level
The role involves leading statistical programming activities, mentoring programmers, overseeing clinical programming deliverables, and ensuring quality and compliance in regulatory submissions.
The summary above was generated by AI

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...

ClinChoice is currently recruiting for a  Manager, Statistical Programming Consultant to join our client’s team —an exciting opportunity to lead impactful statistical strategy in a dynamic environment.

Role Overview

We are seeking an experienced and motivated Manager, Statistical Programming to lead programming activities within the Biometrics group. This role will oversee clinical programming deliverables, drive quality and compliance, support regulatory submissions, and mentor a team of programmers. The ideal candidate will have strong expertise in SAS (and/or R), deep knowledge of CDISC standards, experience with oncology clinical trials, and excellent leadership skills.

Key Responsibilities:Leadership & Strategy

 

  • Lead and mentor a team of statistical programmers, fostering development and high performance.

  • Oversee internal and vendor/CRO programming deliverables, ensuring timelines and quality expectations are met.

  • Establish and maintain programming standards, documentation, and best practices.

  • Support planning, resourcing, and prioritization for programming activities across multiple studies.

Programming & Technical Delivery
  • Oversee development and validation of SDTM and ADaM datasets according to CDISC standards and oncology study requirements.

  • Supervise creation of Tables, Listings, and Figures (TLFs) for clinical study reporting and regulatory submissions.

  • Ensure all deliverables are of high quality, reproducible, and aligned with regulatory expectations (e.g., FDA, EMA).

  • Support automation and efficiency initiatives using SAS and/or R.

  • Perform and review QC checks, resolving programming and data issues.

Cross-Functional Collaboration
  • Partner closely with Biostatistics, Clinical Data Management, Medical Writing, and Regulatory teams.

  • Participate in study team meetings, contributing programming perspective to clinical and data discussions.

  • Support preparation of submission-ready deliverables, including reviewer guides, traceability documents, and regulatory artifacts.

Required Qualifications:
  • Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field.

  • 9–11+ years of statistical programming experience in the pharmaceutical/biotech/CRO environment.

  • Strong proficiency in SAS programming; experience with R is a plus.

  • Expert understanding of CDISC standards (SDTM, ADaM).

  • Experience managing or mentoring programming teams.

  • Demonstrated experience supporting regulatory submissions.

  • Excellent communication skills and ability to work collaboratively across functions.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.


#LI-TT1 #LI-Remote #Manager#Contract

Similar Jobs

23 Minutes Ago
Remote or Hybrid
North Carolina, USA
20-20 Hourly
Junior
20-20 Hourly
Junior
Fintech • Information Technology • Insurance • Financial Services • Big Data Analytics
Customer Care Advocates handle inbound customer service inquiries, resolve complex issues, and ensure exceptional customer experiences. The role requires effective communication, empathy, and problem-solving skills to meet customer needs.
23 Minutes Ago
Remote or Hybrid
North Carolina, USA
20-20 Hourly
Junior
20-20 Hourly
Junior
Fintech • Information Technology • Insurance • Financial Services • Big Data Analytics
Customer Care Advocates provide inbound support for customer service inquiries, resolving complex issues with empathy and effective communication skills. They ensure exceptional customer experiences by understanding needs and delivering appropriate solutions.
33 Minutes Ago
Easy Apply
Remote or Hybrid
USA
Easy Apply
70K-75K Annually
Junior
70K-75K Annually
Junior
eCommerce • Fintech • Food • Mobile • Social Impact
The Administrative Assistant will manage calendars, coordinate travel, support team communications, organize events, and maintain documentation.
Top Skills: Google WorkspaceMS OfficeScheduling Tools

What you need to know about the Austin Tech Scene

Austin has a diverse and thriving tech ecosystem thanks to home-grown companies like Dell and major campuses for IBM, AMD and Apple. The state’s flagship university, the University of Texas at Austin, is known for its engineering school, and the city is known for its annual South by Southwest tech and media conference. Austin’s tech scene spans many verticals, but it’s particularly known for hardware, including semiconductors, as well as AI, biotechnology and cloud computing. And its food and music scene, low taxes and favorable climate has made the city a destination for tech workers from across the country.

Key Facts About Austin Tech

  • Number of Tech Workers: 180,500; 13.7% of overall workforce (2024 CompTIA survey)
  • Major Tech Employers: Dell, IBM, AMD, Apple, Alphabet
  • Key Industries: Artificial intelligence, hardware, cloud computing, software, healthtech
  • Funding Landscape: $4.5 billion in VC funding in 2024 (Pitchbook)
  • Notable Investors: Live Oak Ventures, Austin Ventures, Hinge Capital, Gigafund, KdT Ventures, Next Coast Ventures, Silverton Partners
  • Research Centers and Universities: University of Texas, Southwestern University, Texas State University, Center for Complex Quantum Systems, Oden Institute for Computational Engineering and Sciences, Texas Advanced Computing Center

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account