Biostatistics & Programming

Enabling data-driven decision-making through precision analytics.

ProPharma's Biostatistics & Programming Expertise

At ProPharma, our biostatistics and programming team supports our clients through the entire product development journey and excels in transforming complex data into clear, actionable insights. Our global team ensures around-the-clock support and employs the latest industry standards, actively contributing to organizations like CDISC. We offer a comprehensive suite of services, from clinical study design and regulatory strategy support to clinical study execution, and provide real-time insights into what is happening with your data.

Utilizing advanced tools and languages like SAS, R, and Python, our team ensures high-quality, validated results. Our proven track record includes the successful completion of 10 NDA/BLA submissions in the past three years, demonstrating our commitment to excellence and regulatory compliance across a broad spectrum of therapeutic areas.

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Clinical Study Design

Clinical Study Design

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Regulatory Strategy

Regulatory Strategy

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Clinical Study Execution

Clinical Study Execution

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Additional Services

Additional Services

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Therapeutic Areas

Therapeutic Areas

Clinical Study Design Services

  • Endpoint Selection
  • Analysis Method Determination
  • Sample Size Calculations/Statistical Power (simulations, adaptive design, etc.)
  • Type 1 Error Rate Adjustments 
  • Adaptive Design 
  • Protocol Development (writing and QC) 
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Regulatory Strategy Support

  • General Statistical Guidance/Recommendation
  • Clinical Program Design and Development 
  • FDA Meeting Prep, Attendance, and Follow-up
  • FDA Submission (NDA, BLA, etc.) Strategy, Attendance (Representation), Advisory Committee Support, Ad-Hoc Support, etc.
  • Integrated Summary of Safety and Efficacy (ISS/ISE) for NDA and BLA Submission Support
  • Study Data Standardization Plans (SDSP)
  • Global Regulatory Support for all regulatory agencies (EMA, MHRA, PMDA, etc.) 
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Clinical Study Execution Services

  • Randomization (Plan, Codes, List, etc.) 
  • eCRF Design and Review 
  • Blinding (Plan, Maintenance, etc.) 
  • Statistical Analysis Plan (SAP) 
  • Table, Listing, Figure Shells (TLFs)
  • CDISC Programming, Validation, and Associated Documentation (SEND, SDTM, ADaM) 
  • Statistical Analysis with Formal + Validated Reports (CSR Input and Review)
  • Pharmacokinetic and Pharmacodynamic Analyses 
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Additional Services

  • Data Monitoring Committee (DMC) Services 
  • Health Economics and Outcomes Research (HEOR) 
  • Real World Evidence (RWE) 
  • Legacy CDSIC conversion data (SDTM and ADaM) 
  • Data Reconciliation 
  • Data Curation 
  • Data Visualization 
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Therapeutic Areas Served

We can support statistical analysis and programming for a variety of therapeutic areas, including:

  • Cardiovascular
  • Dermatology
  • Endocrinology
  • Geriatrics
  • GI
  • Hematology
  • Immunology
  • Infectious Disease
  • Inflammatory diseases
  • Neurology
  • Oncology
  • Ophthalmology
  • Pain Management
  • Pediatrics
  • Rare Disease
  • Respiratory
  • Rheumatology
  • Urology
  • Vaccines
  • Women's Health
  • And more
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Comprehensive Biostatistics & Programming Support and Consulting

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Clear Communication

We know that statistics and programming aren’t easily understood, and our team is here to help you know what’s going on with your data, in a way that makes sense and can be...

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Clear Communication

We know that statistics and programming aren’t easily understood, and our team is here to help you know what’s going on with your data, in a way that makes sense and can be explained to those outside the biostatistics and programming realm.

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CDISC Volunteers

We ensure our clients benefit from the most current and compliant practices in the field. Our team members volunteer at CDISC to develop and refine industry standards.

CDISC Volunteers

We ensure our clients benefit from the most current and compliant practices in the field. Our team members volunteer at CDISC to develop and refine industry standards.

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Experienced with Health Authorities

Our teams have vast experience communicating with regulatory agencies worldwide, including FDA, EMA, MHRA, PMDA, Health Canada, TGA, NMPA, and more. 

Experienced with Health Authorities

Our teams have vast experience communicating with regulatory agencies worldwide, including FDA, EMA, MHRA, PMDA, Health Canada, TGA, NMPA, and more. 

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NDA & BLA Submission Experience

We have completed 10 NDA/BLA submissions in the last 3 years. 

NDA & BLA Submission Experience

We have completed 10 NDA/BLA submissions in the last 3 years. 

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Global Team

Our team members are located in five countries across the globe, allowing us to work with our sponsors around the clock. 

Global Team

Our team members are located in five countries across the globe, allowing us to work with our sponsors around the clock. 

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Flexible Approach

Our flexible approach allows us to support our clients in whatever model best suits their needs, whether that is full-service CRO, functional service provider (FSP), or ad-hoc...

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Flexible Approach

Our flexible approach allows us to support our clients in whatever model best suits their needs, whether that is full-service CRO, functional service provider (FSP), or ad-hoc consulting. 

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Our Biostatistics & Programming Consulting and Services

At ProPharma, we redefine the landscape of biostatistics and programming by offering far more than mere statistical analysis. Our diverse team of experts delivers unparalleled support across the entire spectrum of the life sciences journey, ensuring that our clients benefit from a holistic and integrated approach. With best-in-class communication skills, we demystify complex statistical processes, ensuring they are accessible and transparent to all stakeholders. This approach facilitates informed decision-making at every level of engagement and fosters a collaborative environment where insights lead to innovation. 

Our global, highly experienced team operates across time zones, providing around-the-clock support to our sponsors. When combined with our robust processes and global infrastructure, we accelerate project timelines and enhance quality and consistency across deliverables, significantly mitigating risks and optimizing operational efficiencies. We are flexible to support our clients with an outsourcing model that best suits their needs, including full-service CRO, FSP, or ad-hoc consulting.

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Our Infrastructure & Tools

Quality and safety are at the heart of everything we do, especially when working with sensitive clinical trial data. Our team completes all work using our GXP-validated SAS server, and data is moved into and out of our environment through SFTPs.

We have programmers who are fluent in SAS, R, and Python languages, enabling us to work on any data type and conduct any data analysis needed. Our experienced team uses ProPharma's proprietary data visualization tool that enables our sponsors to view their data in real-time and to create their own graphics and dashboards providing them with key insights into their clinical trials in real-time.

Complex Needs Require Custom Solutions

We ensure that your statistical analysis is valid, complete, supported by the data, and presented in a way that is easy to understand. If you need support for your study data, ProPharma's experienced biostatistics and programming team can help. 

Biostatistics & Programming Experts

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News & Insights

Decoding FDA’s Recent Advertising Enforcement Actions

September 17, 2025

Decoding FDA’s Recent Advertising Enforcement Actions

Key takeaways from FDA’s latest enforcement letters which mark a major shift in advertising oversight and highlight new compliance risks for Sponsors.

FDA Launches Crackdown on Deceptive Drug Advertising

September 10, 2025

FDA Launches Crackdown on Deceptive Drug Advertising

FDA’s new crackdown on deceptive drug advertising reshapes pharma marketing. Discover implications for sponsors, compliance strategies, and patient trust.

Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Companies: A Tale of Two Paths

September 10, 2025

Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Co...

Discover two distinct paths for creating a global audit strategy in medical device companies, focusing on harmonization and compliance efficiency ahead of FDA's 2026 QMSR changes.

ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice President, Labeling & Strategy to Advance Strategic Labeling & Promotional Review

July 8, 2025

ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...

ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Appoints Brian Tuttle as Chief Financial Officer

October 21, 2024

ProPharma Appoints Brian Tuttle as Chief Financial Officer

ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Case Study Leading Technology Selection Decision Making - ProPharma

September 15, 2025

Leading Technology Selection Decision Making

Discover how ProPharma enabled a leading global biopharma to overcome fragmented clinical sample management and outdated manual processes. Faced with disparate systems, off-site inventories, and...

Guide Your Roadmap to European Drug Approval: The Complete Solution - ProPharma

September 9, 2025

Your Roadmap to European Drug Approval: The Complete Solution

Discover how ProPharma simplifies the complex journey to European drug approval by acting as a full-service Marketing Authorization Holder partner. From crafting regulatory strategies and...

Whitepapers Agility Meets Expertise: The ProPharma FSP Approach - ProPharma

September 3, 2025

Agility Meets Expertise: The ProPharma FSP Approach

Discover how ProPharma elevated the Functional Service Provider (FSP) Model by blending specialized expertise, agile resourcing, and innovative technology. By building dedicated teams, streamlining...

AI in Medical Information: Who Holds the Responsibility?

October 16, 2025

AI in Medical Information: Who Holds the Responsibility?

In Medical Information (MI) and beyond, key questions arise: Who ensures accuracy, compliance, and ethical use — individual contributors, leadership, pharma clients, or technology providers? And what...

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

September 23, 2025

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

Medical, Legal, and Regulatory (MLR) review meetings are a critical checkpoint in the promotional material approval process, but they’re often a source of bottlenecks, conflicting feedback, and...

The Path to Clarity – Unlocking the Power of Data Standards for Digital Transformation

September 17, 2025

The Path to Clarity – Unlocking the Power of Data Standards for Digital Transformation

In today’s data-driven R&D environment, fragmented and incompatible data can stall innovation. This webinar, led by experts from ProPharma and CSL Behring, reveals how robust data standards,...

News & Insights

Decoding FDA’s Recent Advertising Enforcement Actions

September 17, 2025

Decoding FDA’s Recent Advertising Enforcement Actions

Key takeaways from FDA’s latest enforcement letters which mark a major shift in advertising oversight and highlight new compliance risks for Sponsors.

FDA Launches Crackdown on Deceptive Drug Advertising

September 10, 2025

FDA Launches Crackdown on Deceptive Drug Advertising

FDA’s new crackdown on deceptive drug advertising reshapes pharma marketing. Discover implications for sponsors, compliance strategies, and patient trust.

Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Companies: A Tale of Two Paths

September 10, 2025

Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Co...

Discover two distinct paths for creating a global audit strategy in medical device companies, focusing on harmonization and compliance efficiency ahead of FDA's 2026 QMSR changes.

Previous Post Arrow Next Post Arrow
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice President, Labeling & Strategy to Advance Strategic Labeling & Promotional Review

July 8, 2025

ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...

ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Appoints Brian Tuttle as Chief Financial Officer

October 21, 2024

ProPharma Appoints Brian Tuttle as Chief Financial Officer

ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.

Previous Post Arrow Next Post Arrow
ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Previous Award Arrow Next Award Arrow
Case Study Leading Technology Selection Decision Making - ProPharma

September 15, 2025

Leading Technology Selection Decision Making

Discover how ProPharma enabled a leading global biopharma to overcome fragmented clinical sample management and outdated manual processes. Faced with disparate systems, off-site inventories, and...

Guide Your Roadmap to European Drug Approval: The Complete Solution - ProPharma

September 9, 2025

Your Roadmap to European Drug Approval: The Complete Solution

Discover how ProPharma simplifies the complex journey to European drug approval by acting as a full-service Marketing Authorization Holder partner. From crafting regulatory strategies and...

Whitepapers Agility Meets Expertise: The ProPharma FSP Approach - ProPharma

September 3, 2025

Agility Meets Expertise: The ProPharma FSP Approach

Discover how ProPharma elevated the Functional Service Provider (FSP) Model by blending specialized expertise, agile resourcing, and innovative technology. By building dedicated teams, streamlining...

Previous Resource Arrow Next Resource Arrow
AI in Medical Information: Who Holds the Responsibility?

October 16, 2025

AI in Medical Information: Who Holds the Responsibility?

In Medical Information (MI) and beyond, key questions arise: Who ensures accuracy, compliance, and ethical use — individual contributors, leadership, pharma clients, or technology providers? And what...

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

September 23, 2025

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

Medical, Legal, and Regulatory (MLR) review meetings are a critical checkpoint in the promotional material approval process, but they’re often a source of bottlenecks, conflicting feedback, and...

The Path to Clarity – Unlocking the Power of Data Standards for Digital Transformation

September 17, 2025

The Path to Clarity – Unlocking the Power of Data Standards for Digital Transformation

In today’s data-driven R&D environment, fragmented and incompatible data can stall innovation. This webinar, led by experts from ProPharma and CSL Behring, reveals how robust data standards,...

Previous Webinar Arrow Next Webinar Arrow