Biostatistics & Statistical Programming

Services

Biostatistics & Statistical Programming

Biostatistical services, including SAP development, statistical programming in SAS, analysis, submission-ready services and statistical reports are customized and designed specifically to meet the project requirements.
Introduction
We manage all aspects of your data—from study startup to submission and closely collaborate with Data Management and Clinical teams to ensure that the timelines and milestones of the trial are met.
Introduction
Study Design

Well-designed clinical trials are essential to successful clinical development. Many compounds do not reach market because of flaws in the design stage. To optimize your study, you need a partner who will help you plan the course of your clinical trial, proactively improve predictability, reduce risks and help you reach Go/No-Go decisions faster. Our experienced biostatistician will partner with you to provide the optimal clinical trial design, looking for efficacy signals to achieve better outcomes for the resources spent. This includes developing the synopsis and the full protocol document, calculating the sample size for conventional, group-sequential or adaptive designs (including Bayesian designs), running trial simulations, and proposing innovative solutions to expedite and optimize chances of success of your clinical trial.

Study Design Services include:

Selection of the patient population;

  • Choice of efficient and reliable endpoints, as well as validation of surrogate endpoints
  • Sample size calculation
  • Sample size re-assessment during the study (blinded or unblinded using DMC)
  • Trial simulations
  • Adaptive trial set-up
  • Factorial and cross-over designs for selected situations
  • Randomization
  • Statistical analysis using of state-of-the-art and novel methods
  • Interim analysis
  • Experience in assisting clients in dealing with regulatory authorities, including the FDA and EMA, to discuss the study design or to defend the study results
Randomization

Biostatistics-Driven IRT/IWRS: Unbiased Assessment of Outcomes in Clinical Trials

We will provide the most appropriate randomization methodology to meet your trial’s specific needs – this could be dynamic randomization (minimization), preplanned schedule (balanced or unbalanced), stratified randomization according to prognostic factors, multi-stage or any other method to help customize your study goals. The IRT/IWRS is fully integrated with our EDC system, and is adjustable throughout the clinical trial with no downtime.

Comprehensive Data Monitoring Comittee Services

A DMC—Data Monitoring committee or DSMB—Data Safety Monitoring Board, is an independent panel of experts who periodically review clinical trial data to ensure integrity, scientific rigor and patient safety in clinical studies. To support this critical function, Bioforum provides comprehensive Data Monitoring Committee services designed for pharmaceutical and biotech companies.

  • Data Monitoring Committee expertise:
    • Provide an independent blinded/un-blinded statistician
    • Charter design or review
    • Safety and interim efficacy analyses
    • Design of output templates
    • Data transfer from all parties: Sponsor, CROs, central laboratory, etc.
    • Data quality review
    • Blinded or unblinded analyses
    • Produce and distribute tables, figures and listings for interim analyses
    • Writing of blinded/unblinded reports
  • Secure Data Sharing:
    • A secure data sync and sharing service with flexible storage options and access rights
    • Encrypts data over the web integrating stringent security requirements
Standardized Data (SDTM)

Standardization of study data is needed for submission to regulatory authorities or to integrate with other systems such as data warehouses. We have many years of experience in assisting customers to transfer clinical data in CDISC SDTM (Study Data Tabulation Model) format or other customer-specific formats.

Analysis Data (ADaM)

Analysis data are needed for submission to regulatory authorities and the generation of analysis outputs. We have many years of experience in assisting customers to transfer clinical data in CDISC ADaM (Analysis Data Model) format or other customer-specific formats.

Analysis Outputs (TFLs)

Analysis outputs (Tables, Figures and Listings, TFLs) are required to perform the analysis for a clinical trial. We have many years of experience in assisting customers to create TFLs per the requirements of a specific clinical trial.

Data Integration

Bioforum has helped customers with many integrated safety (ISS) and efficacy (ISE) summaries for submission to regulatory authorities.

Reports

Bioforum is well equipped to produce periodic and safety committee reports, for example for DSURs and DMCs.

Independent Quality Review

Bioforum has assisted several customers to perform independent quality review on deliverables produced by an external party. This helps the customer ensure quality of deliverables and avoid costly rejections or time delays later in the approval process.

Our Expertise
Innovative Approach
Streamlined Processes & Systems
SDTM
CDISC Study Data Tabulation Model
ADaM
CDISC Analysis Dataset Model
Analysis Outputs
Tables, Listings & Figures
Programming Systems

Meet our team

Bioforum employs an experienced Biostatistics and Statistical Programming team that will provide you with valuable information through every step of the way.

Paul Malan
VP, Biostatistics
Paul brings 17 years of experience in planning and executing clinical trials, study designs, statistical analysis and reporting. He joined Bioforum from IQVIA, where he began his career as a statistician in 2003. Over the years, Paul held roles of increasing responsibility at IQVIA, moving up the ranks to serve as Country Manager for the IQVIA Biostatistics and Statistical Programmer groups in South Africa. In addition, Paul led a major FSP program for IQVIA, overseeing the work of more than 235 biostatisticians and statistical programmers dedicated to a large, multinational pharmaceutical company. As the Vice President of Biostatistics & Training, Paul drives the growth and expansion of Bioforum’s biostatistics capabilities and expertise, responsible for the FSP division and Bioforum Academy. Certified by the South-African University of the Free State, Paul holds B.Com in Econometrical Analysis, B.Com in Statistics (Hons) and M.Com in Statistics. Paul is also a member of the South African Statistical Association
Bremer Louw
VP, Biometrics Operations & Business Development
Bremer holds a National Diploma in Information Technology and a Batchelor’s degree in Project Management. He brings 15 years of experience of which the first 12 years were in IQVIA Data Management where he started off as a Clinical Database Programmer and moved through the ranks to heading up a SAS programming team as part of a major FSP with a top 10 Pharma. He was Associate Director overseeing delivery, processes, customer relations, resourcing and much more for a team of 60+ programmers. He started with Bioforum in 2019 starting the Biometrics department in South Africa. Currently he is responsible for performance measurements, growth planning, quality, business development and IT systems.
Dafna Otiker
VP, Biometrics Delivery
Dafna has been a part of the Bioforum team for the last 13 years and has been leading the statistical programming group for the past 5 years. She has supported and led studies in the area of data management, statistical programming, and regulatory submissions in all phases, encompassing numerous therapeutic areas. Dafna holds a B.Sc. from the Hebrew University and an MBA from the College of Management Academic Studies, Bio-MBA Program. As Vice president of Biometrics delivery, Dafna is responsible for overseeing delivery of all projects conducted in Biometrics department and supports the finance and BD teams.
Chaviva Peretz Rosenlum
Senior Principal, Biostatistician
Chaviva holds a BA & MA in statistics from the Hebrew University. Chaviva has an overall of more than 18 years of experience in the clinical studies arena as biostatistician and a CDISC expert. She has been with Bioforum from 2010, and assisted in establishing the biostatistics and statistical programming group. Specialized in CDISC deliverables and used as CDISC SME on numerous FDA submissions. She is currently also supporting all aspects of biostatistics work in Bioforum, and performs as a mentor for other programmers and biostatisticians. Chaviva also supports supervision of projects and clients.
Neels Vorster
Associate Director
Neels completed his National Diploma in Information Technology in 2002 at which time he entered the CRO industry as a Clinical Data Programmer. He worked in this role for a few years before moving into the management space leading teams of Clinical Programmers for a large CRO. In 2016 he obtained his bachelor’s degree in management and leadership, further solidifying his expertise on people and business management in the Clinical Programming domain. With 19 years’ experience in this field, he moved to Bioforum taking up the position of Associate Director for Biostatistics and Statistical Programming. Neels brings with him years of experience in global collaboration and building lasting relationships across departments, organizations and operational functions. Neels is now serving as the delivery oversight for one of our delivery teams.
Daniel Rolo
Associate Director
Daniel holds a B.Sc. degree majoring in Computer Science and Geographic Information Systems from the University of the Free State and has over 9 years of experience in the industry. During this time, Daniel held various positions and roles ranging from being the lead programmer on large portfolios of studies, to providing operational oversight in both partnership and non-partnership resourcing models. Daniel has in addition to serving in leadership roles within the operational space, provided strategic leadership in the realm of business innovations and standards/process optimization. Daniel has a passion for people management, developing talent and helping customers and colleagues alike to succeed in their goals. Daniel is now serving as the delivery oversight for one of our delivery teams.
Hofit Jacoby
Associate Director
Hofit holds a MSc. degree in Agroecology & Microbiology from the Hebrew University of Jerusalem, Israel and has a CRA certification. She brings with her 8 years of experience in leading high performing teams and was previously involved in innovative healthcare research as a laboratory assistance at the Weizmann institute of science. Hofit joined Bioforum in 2016, and has worked in a wide range of roles on statistical programming as well as collaborations with different departments. Among her responsibilities she was involved in EDC building as Design Architect in collaboration with the data management department. She later became a statistical programmer and project manager and to take the role of QA associate of the statistical programming department while serving as a team leader. During her time as a project manager in the statistical programming department Hofit led projects involving all phases across a variety of therapeutic areas. Hofit is now serving as the delivery oversight for one of our delivery teams.
Paul Malan
VP, Biostatistics
Paul brings 17 years of experience in planning and executing clinical trials, study designs, statistical analysis and reporting. He joined Bioforum from IQVIA, where he began his career as a statistician in 2003. Over the years, Paul held roles of increasing responsibility at IQVIA, moving up the ranks to serve as Country Manager for the IQVIA Biostatistics and Statistical Programmer groups in South Africa. In addition, Paul led a major FSP program for IQVIA, overseeing the work of more than 235 biostatisticians and statistical programmers dedicated to a large, multinational pharmaceutical company. As the Vice President of Biostatistics & Training, Paul drives the growth and expansion of Bioforum’s biostatistics capabilities and expertise, responsible for the FSP division and Bioforum Academy. Certified by the South-African University of the Free State, Paul holds B.Com in Econometrical Analysis, B.Com in Statistics (Hons) and M.Com in Statistics. Paul is also a member of the South African Statistical Association
Bremer Louw
VP, Biometrics Operations & Business Development
Bremer holds a National Diploma in Information Technology and a Batchelor’s degree in Project Management. He brings 15 years of experience of which the first 12 years were in IQVIA Data Management where he started off as a Clinical Database Programmer and moved through the ranks to heading up a SAS programming team as part of a major FSP with a top 10 Pharma. He was Associate Director overseeing delivery, processes, customer relations, resourcing and much more for a team of 60+ programmers. He started with Bioforum in 2019 starting the Biometrics department in South Africa. Currently he is responsible for performance measurements, growth planning, quality, business development and IT systems.
Dafna Otiker
VP, Biometrics Delivery
Dafna has been a part of the Bioforum team for the last 13 years and has been leading the statistical programming group for the past 5 years. She has supported and led studies in the area of data management, statistical programming, and regulatory submissions in all phases, encompassing numerous therapeutic areas. Dafna holds a B.Sc. from the Hebrew University and an MBA from the College of Management Academic Studies, Bio-MBA Program. As Vice president of Biometrics delivery, Dafna is responsible for overseeing delivery of all projects conducted in Biometrics department and supports the finance and BD teams.
Chaviva Peretz Rosenlum
Senior Principal, Biostatistician
Chaviva holds a BA & MA in statistics from the Hebrew University. Chaviva has an overall of more than 18 years of experience in the clinical studies arena as biostatistician and a CDISC expert. She has been with Bioforum from 2010, and assisted in establishing the biostatistics and statistical programming group. Specialized in CDISC deliverables and used as CDISC SME on numerous FDA submissions. She is currently also supporting all aspects of biostatistics work in Bioforum, and performs as a mentor for other programmers and biostatisticians. Chaviva also supports supervision of projects and clients.
Neels Vorster
Associate Director
Neels completed his National Diploma in Information Technology in 2002 at which time he entered the CRO industry as a Clinical Data Programmer. He worked in this role for a few years before moving into the management space leading teams of Clinical Programmers for a large CRO. In 2016 he obtained his bachelor’s degree in management and leadership, further solidifying his expertise on people and business management in the Clinical Programming domain. With 19 years’ experience in this field, he moved to Bioforum taking up the position of Associate Director for Biostatistics and Statistical Programming. Neels brings with him years of experience in global collaboration and building lasting relationships across departments, organizations and operational functions. Neels is now serving as the delivery oversight for one of our delivery teams.
Daniel Rolo
Associate Director
Daniel holds a B.Sc. degree majoring in Computer Science and Geographic Information Systems from the University of the Free State and has over 9 years of experience in the industry. During this time, Daniel held various positions and roles ranging from being the lead programmer on large portfolios of studies, to providing operational oversight in both partnership and non-partnership resourcing models. Daniel has in addition to serving in leadership roles within the operational space, provided strategic leadership in the realm of business innovations and standards/process optimization. Daniel has a passion for people management, developing talent and helping customers and colleagues alike to succeed in their goals. Daniel is now serving as the delivery oversight for one of our delivery teams.
Hofit Jacoby
Associate Director
Hofit holds a MSc. degree in Agroecology & Microbiology from the Hebrew University of Jerusalem, Israel and has a CRA certification. She brings with her 8 years of experience in leading high performing teams and was previously involved in innovative healthcare research as a laboratory assistance at the Weizmann institute of science. Hofit joined Bioforum in 2016, and has worked in a wide range of roles on statistical programming as well as collaborations with different departments. Among her responsibilities she was involved in EDC building as Design Architect in collaboration with the data management department. She later became a statistical programmer and project manager and to take the role of QA associate of the statistical programming department while serving as a team leader. During her time as a project manager in the statistical programming department Hofit led projects involving all phases across a variety of therapeutic areas. Hofit is now serving as the delivery oversight for one of our delivery teams.
Frequently Asked Questions
What services do you offer?
Bioforum offers end-to-end biostatistical and statistical programming services. This includes assistance with study design, writing the Statistical Analysis Plan, receiving raw data from Data Management and other vendors, converting to standard and analysis data formats such as SDTM and ADaM, generating analysis outputs (Tables, Listings & Figures) and authoring the statistical section of the CSR. Bioforum can also help you with data conversion to other data standards, legacy study support, statistical analysis, data integrations (ISS\ISE), DMC\DSMB report and unblinded support and independent quality review.
What makes you different than other CROs?
As a mid-size CRO, we are big enough to cover all your biostatistics and statistical programming needs, and small enough to ensure that all our projects are being managed effectively, regardless of size or scope. With a customer based including pharma, academia and non-profit, CROs and EDC companies, the broad spectrum of clinical research sectors, combined with experience in a variety of therapeutic areas over all study phases, promotes skill development in all areas of statistical programming. Our innovative culture is show-cased by the recent launch of our Jet-ConvertTM technology, an SDTM conversion tool that uses machine learning with no SAS involved, resulting in significant reduction of effort required to produce SDTM datasets of superior quality.
How do you ensure quality?
Through our independent Quality Assurance (QA) department and quality management system, we ensure that both processes and deliverables meet the industry standards and customer requirements. We leverage internal processes like quarterly internal audits, periodic review of controlled documents, continuous training, individual development plans, continuous process improvement, timely and thorough action on deviations, audit findings, customer complaints and CAPAs to maintain our reputation for quality. We are also ISO 9001:2015 certified.
In what therapeutic areas do you have experience?
Bioforum has experience in many different therapeutic areas. These include (in descending order of experience): oncology, neurology, psychiatry, cardiology, orthopedics, dermatology, gastroenterology, ophthalmology, gynecology, and immunology. This list is not inclusive–we listed here just the top 10, and there are many more in which we have experience.