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 your 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.

Bioforum has a team of biostatistics consultants to solve all your biostatistics requirements, whether regulatory, strategy or technically related. Our consultants, each with at least 20 years experience, will advise or provide oversight on a wide variety of topics, it does not matter if it is a small task or working on a large project involving multiple trials

 

Nissim Sasson

Nissim Sasson holds a master’s degree in Biostatistics from the University of Haifa, Israel. His career as biostatistician started 22 years ago, working as project statistician on lupus, Crohn’s disease and multiple sclerosis trials at Teva. In 2011 Nissim was assigned as Lead Biostatistician for multiple sclerosis at Teva, and in 2015 became biostatistics head for multiple sclerosis and neurodegenerative disease. This position involved input and consultation on protocols, clinical development plans, clinical endpoint assessment, sample size planning, and advanced methodology approaches for efficient decision making, including adaptive designs and Bayes methodology. Nissim was also responsible for the selection of CROs where required.

In 2018 Nissim joined Bioforum as Head of Biostatistics, overseeing the biostatistics group. In 2019, he decided to focus on biostatistics consulting work, consulting to pharma and biotech companies for various indications. His experience in neurology include work on Parkinson’s disease, amyotrophic lateral sclerosis, and others. Scope typically includes consulting on advanced sample size calculations, interim analyses (proven efficacy or futility), position papers on study design features (example adaptive, group sequential, sample size re-assessment, etc.), and statistical sections in protocols/synopsis.

During his career as biostatistician Nissim has interacted with regulatory authorities on statistical methodology and strategy, provided guidance on regulatory submission strategies, and acted as unblinded statistician (including voting member) for Data Monitoring Committees (DMCs).

Ofra Barnett-Griness

Ofra Barnett-Griness obtained her Ph.D. in Statistics in 1998, after which she joined Teva for 4 years, first as a biostatistician working on Parkinson disease trials and later as biostatistics consultant. In 2002 Ofra started lecturing at the Department of Medicine at the Technion in Haifa, Israel. During this time she also provided biostatistics support for studies in Genetic Epidemiology and Personalized Medicine and contributed to Electronic Medical Records- based observational studies, which she is still involved with today.

In 2008 Ofra re-joined Teva as Chair of Independent Review Committee and Internal consultancy. In addition, she led several initiatives on strategic statistical aspects in areas of multiple sclerosis and migraine. She also acted as statistical head for oncology and non-alcoholic steatohepatitis (NASH).

Ofra joined Bioforum in January 2019, to provide statistical leadership for overall and individual study strategy for our customers. She consults on aspects of study design, endpoint selection, sample size considerations, and advance statistical methodology. These incudes regulatory interaction with FDA and other agencies and participating in DSMB meetings from time to time.

Eva Krusinska

Eva Krusinska is an experienced biostatistician and pharmaceutical executive. She holds a master’s degree in computer science, and two doctoral degrees in Measurement Science / Biostatistics. She has authored over 190 publications and presentations, and was awarded research fellowships in Germany, Sweden, and France. Dr Krusinska has over twenty years of managerial and leadership experience in the pharmaceutical industry in the USA, both on the CRO and the sponsor’s side of the business.

In her more than 20 years working in the clinical research environment, Dr Krusinska’s vast experience in clinical trial methodology include cross-over and parallel designs, sequential and adaptive designs, categorical data analysis, longitudinal data analysis, multiplicity control, composite endpoints, and multivariate analysis. In addition to consulting on statistical methodology, Dr Krusinska advises on strategy for submission content, including gap analysis of existing data packages, preparation of integrated submission documents, response to international regulatory queries, regulatory issues including participating in FDA/EMEA meetings, and Advisory Committee meeting preparation and participation. Eva participated in many Special Protocol Assessments (SPA), and sat on Data Safety and Monitoring Boards (DSMBs) as independent biostatistician.

From a clinical program perspective, she provides statistical advice on clinical development plans, statistical input into study protocols, regulatory briefing documents, integrated summaries of efficacy and safety, as well as scientific publications. She provides statistical consulting in all phases of clinical development, post-marketing commitments, claim support, Real World Evidence, disease registries, observational studies, and retrospective data analysis.

Her therapeutic area experience includes rare diseases, endocrine & metabolic disorders, pulmonary diseases, allergy, cardiology, dermatology, genitourinary disorders, nephrology, oncology & hematology, CNS, virology, infectious diseases gastrointestinal diseases, pain, addiction, oral care.

 

Maëva Dupuis

Maëva Dupuis is a mathematician and statistician and holds a master’s degree in Mathematics from the University of Lyon. Her experience working in the field of clinical trials span more than 20 years, during which she had the opportunity to work with research centres, CROs and pharmaceutical laboratories.

Maëva has been offering her services as a biostatistics consultant since 2011. In recent years she focussed on supporting global clinical development strategies for phase 2 and phase 3 programs, as well as pivotal trials. This includes regulatory methodological exchanges with the FDA and EMA. In addition, she is regularly asked to join expert committee meetings (DMCs) during the follow-up of studies, both as biostatistics support and as an independent biostatistician. This includes consulting and advising on adaptive designs.

Maëva has worked in many therapeutic areas, with more experience in ophthalmology, neurology, gastro-intestinal and rare diseases including gene therapy. She gained significant experience working on pre-submission studies (phase I – III) and is also familiar working on medical device trials.

Leah Price

Leah Price’s career as a biostatistician started in 2001, working as a research biostatistician in oncology at the Memorial Sloan Kettering Cancer Centre in New York. In 2005 Leah started provided statistical consultancy services on survey design, data analysis and report creation for various customers, including support on publishing papers. She joined the New York University Medical Centre as a Graduate Research Biostatistician in 2006, supporting doctors doing research on melanomas as well as the international consortium for myeloproliferative disorders. She completed her doctorate in 2013 while at the Centre, and in 2014 she started her own consultancy firm to consult on study design, statistical analyses, sample size estimation, survey design, Case Report Form (CRF) development, Statistical Analysis Plans (SAP) and advanced statistical methods. Her customers include hospitals, CROs, and pharmaceutical companies.

Leah joined Bioforum in 2018 and provides statistical oversight on studies. This includes looking at statistical aspects of the study design, SAP development and review, review of study Tables, Listings and Figures (TLFs), and review of statistical sections of Clinical Study Reports (CSRs) and publications. She regularly interacts with DSMB members as statistical expert.

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.
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