Biostatistics

Biostatistics Services
 
At Stark Pharma, our Biostatistics services provide the scientific and statistical foundation for evidence-based decision-making across clinical development, regulatory submissions, and post-marketing studies. We support pharmaceutical, biotechnology, and medical device companies with advanced statistical design, analysis, and reporting aligned with global regulatory standards.

Our team of experienced biostatisticians collaborates with clients from Phase I to Phase IV, helping ensure that studies are statistically sound, regulatory-ready, and optimized for speed and accuracy.
 
🔍 Our Core Biostatistics Capabilities
  • Study Design & Protocol Consultation
    Selection of appropriate study design (parallel, crossover, adaptive, etc.) and development of statistical methodologies that align with clinical objectives and regulatory expectations.
  • Statistical Analysis Plans (SAPs)
    Authoring detailed SAPs that outline hypotheses, analysis populations, statistical tests, and handling of missing data in accordance with ICH E9 and other guidance.
  • Randomization & Blinding
    Creation of randomization schedules and implementation of blinding procedures to minimize bias and ensure trial integrity.
  • Data Analysis & Reporting
    Execution of descriptive and inferential analyses using SAS, R, or Python, including efficacy, safety, subgroup, and sensitivity analyses.
  • CDISC Compliance (SDTM/ADaM)
    Mapping and programming of clinical trial data into CDISC-compliant formats for submission to FDA, EMA, and other agencies.
  • Interim Analysis & DMC Support
    Planning and execution of interim analyses with support for Data Monitoring Committees (DMCs) and Independent Review Boards (IRBs).
 
Why Stark Pharma for Biostatistics?
✅ Deep expertise in clinical trial statistics for drugs, biologics, and devices
✅ Full compliance with ICH, FDA, EMA, and CDISC standards
✅ Integrated with data management, medical writing, and regulatory teams
✅ Transparent, validated statistical programming in SAS, R, and Python
✅ Proven record of supporting global submissions and publications

Our Core Biostatistics Capabilities

Protocol Design & Statistical Planning

We collaborate closely with clinical and regulatory teams to develop sound statistical methodologies, define endpoints, and ensure your trial design is scientifically rigorous and regulatory-compliant.

Sample Size Estimation & Randomization

Our statisticians use validated software to determine optimal sample sizes and create randomization schedules that minimize bias and support reproducibility.

Interim & Final Statistical Analysis

We perform descriptive, inferential, and advanced statistical analyses using SAS and R. Our services include interim looks, endpoint analysis, survival analysis, and subgroup evaluations to support DSMB reviews and regulatory decisions.

Data Monitoring & DSMB Support

Stark Pharma provides Data Safety Monitoring Board (DSMB) support including data blinding/unblinding, interim reports, and statistical advice for ongoing risk-benefit evaluation.

Clinical Study Report (CSR) Statistical Inputs

We prepare statistically accurate tables, listings, and figures (TLFs) for inclusion in CSRs, ensuring clarity and precision in reporting outcomes to health authorities.

why ChooseStark Pharma for Biostatistics?

Deep Therapeutic Expertise

Our team supports a wide range of indications—oncology, immunology, cardiovascular, rare diseases, and more—with strong experience in both early-phase and late-stage trials.

Regulatory-Ready Deliverables

We ensure your statistical outputs meet ICH E9, CDISC, and FDA/EMA submission standards—reducing delays and rework in your submission timelines.

Full Integration with Clinical Operations

We work hand-in-hand with data managers, medical writers, and regulatory teams to ensure seamless communication and consistent data interpretation.