P-Product

P-Product, a leading and innovative company in Software development and Data solutions, is looking for an experienced Senior SAS Programmer to join our dynamic team and contribute programming support to the statistics and programming department across a wide range of projects, clients and therapeutic areas. You will have a vital role in helping our clinical trials and drug development processes succeed.

Key Responsibilities:

•Perform SAS programming to create, validate, and maintain analysis datasets, tables, listings and figures for clinical trials and reports according to study protocol and statistical analysis plans.

•Lead the clinical trials flow development from study protocols development to final data analysis, documentation and provisioning the datasets for regulatory submission.

•Adhere to GCP, ICH, and other regulatory guidelines for pharmaceutical data reporting, managerial, scientific and technical tasks.

•Integrate data from different sources and ensure that the datasets are consistent and reliable.

•Collaborate closely with various teams and professionals, such as researchers, data analysts, biostatisticians, data managers and other key stakeholders, to ensure data quality and integrity and observance of regulatory, industry and company standards.

•Coach and mentor junior SAS programmers and create a learning and growth environment.

Required Knowledge and Skills:

•BSc, MSc or PhD in Statistics, Mathematics, Computer Science, or related field.

•5+ years of extensive programming experience in SAS in a clinical trial environment.

•Extended experience with SAS/BASE, SAS/MACRO, SAS/GRAPH and SAS/STAT.

•Professional knowledge and experience with CDISC clinical data standards, such as CDISC, ADaM and SDTM.

•Proven ability to develop specifications for datasets and outputs of any complexity according to the requirements, as well as independently write SAS programming code and validation scripts in a good quality manner.

•Proven statistical expertise, especially in efficacy outputs programming.

•Excellent knowledge of drug development processes and regulatory submission requirements.

•Exceptional analytical and problem-solving skills, strong organizational and communications skills, high attention to detail and commitment to accuracy, proactive mindset and capability to work independently as well as in a team environment.

Will Be a Plus:

•SAS certification.

•Team leading and mentoring experience.

Необхідні навички

Key Responsibilities:

• 1+years experience with DSP

• DSP algorithm optimization for a low-level programming language (С, intrinsics, assembler)

• Porting float-point to fixed-point implementation

• Testing and verification of DSP solution in a simulator or emulator (on the board)

Required Skills:

• Strong C language skills

• Pre-intermediate level of the English language (documentation, emailing and verbal communication)

Required Knowledge:

• DSP theory: Filters, FFT, division, sqrt, re-sampler, etc.

• Approximation: log, exp, sin, cos, etc.

• Linear Algebra

Буде плюсом

Will Be a Plus:

• Practical knowledge of DSP platforms

• С++, intrinsics, assembler languages

• Eclipse

• Batch files

• MS Visual Studio

• MS VS code

• MATLAB: DSP System Toolbox, Linear Algebra

• Python

• GitHub

• Shell

• Audio files format

• Linux (Ubuntu)

Пропонуємо

We offer:

• Competitive compensation

• Full accounting assistance and support

• Regular annual vacation is 20 working days off

• 100% paid sick leave upon provision of the relevant document(s)

• Holidays are provided according to the residence country Law

• Improvement of the English language knowledge with our teacher

• Smart and useful presents for our employees and their kids

• Great atmosphere, creative corporate parties, and true individual approach.

Обов’язки

Key Responsibilities:

• DSP algorithm optimization for low-level programming language (С, intrinsics, assembler)

• Porting float-point to fixed-point implementation

• Testing and verification of DSP solution in a simulator or emulator (on the board)

Про проєкт

We are looking for a software engineer to work with different audio DSP algorithms, port them to fixed-point implementation, design test benches for project verification, communicate with customers and discuss solutions, design functions for a DSP library for float and fixed-point implementation.

We are seeking a highly skilled and experienced Senior Biostatistician to join our team. This role involves providing advanced statistical expertise and leadership for clinical trials conducted by our clients in the pharmaceutical, biotechnology, and medical device industries. The Senior Biostatistician will be responsible for ensuring statistical integrity in trial design, data analysis, and reporting while maintaining close collaboration with cross-functional teams. Your contributions will play a vital role in delivering high-quality results and advancing healthcare solutions.

Key Responsibilities:

• Study Design and Statistical Planning:
  • Collaborate with clinical and project teams to design clinical trials, ensuring robust statistical methodologies and appropriate sample size calculations.
  • Develop and review statistical sections of study protocols and Statistical Analysis Plans (SAPs), detailing statistical techniques, data handling, and endpoints.
• Data Analysis and Reporting:
  • Perform and oversee complex statistical analyses, including hypothesis testing, survival analysis, and mixed models.
  • Generate and review statistical outputs (tables, figures, and listings) for clinical study reports (CSRs) and regulatory submissions.
  • Ensure timely delivery of high-quality statistical analyses in compliance with regulatory standards and study requirements.
• Regulatory Compliance:
  • Ensure all statistical analyses are compliant with ICH, FDA, EMA, and other relevant regulatory guidelines.
  • Prepare documentation for regulatory submissions and address agency queries related to statistical methodologies.
• Cross-Functional Collaboration:
  • Work closely with clinical, programming, data management, and project management teams to ensure alignment on statistical methodologies and timelines.
  • Serve as the primary statistical point of contact for internal teams and external clients, providing clear updates and resolving issues proactively.
• Quality Assurance:
  • Implement and oversee quality control measures, performing validation of datasets and statistical outputs to ensure data integrity and accuracy.
  • Address critical statistical issues by implementing corrective actions and ensuring adherence to best practices in data handling.
• Mentorship and Leadership:
  • Mentor and guide junior statisticians and team members, fostering a collaborative and learning-focused environment.

  • Provide training on statistical techniques and regulatory standards to enhance team capabilities.

     

Qualifications requirements:

• Education:
  • PhD or Master’s degree in Biostatistics, Statistics, Mathematics, or a related field.
• Experience:
  • Minimum of 5 years of experience in biostatistics within a CRO, pharmaceutical, or biotechnology environment.
  • Strong experience in clinical trials, preferably across multiple therapeutic areas.
  • Solid understanding of FDA, EMA, and ICH guidelines, as well as regulatory submission processes.
• Technical Skills:
  • Proficiency in statistical programming languages, particularly SAS (preferred) and/or R.
  • Familiarity with CDISC standards, including SDTM and ADaM.
  • Knowledge of survival analysis, mixed models, non-linear models, and other advanced statistical techniques.
• Other Skills:
  • Excellent communication skills with the ability to explain complex statistical concepts to non-statisticians.
  • Strong problem-solving abilities and attention to detail.

  • Ability to manage multiple projects simultaneously while ensuring high standards of data quality and adherence to timelines.

     

Preferred Qualifications:

• Expertise in programming languages such as Python or JavaScript will be beneficial
• Experience in submission-related interactions with regulatory authorities would be a significant advantage.