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Principal Statistical Programmer
hace 2 meses
Position Overview
The Senior Biostatistical Programmer will take charge of one or more clinical studies, ensuring the creation, upkeep, and validation of annotated Case Report Forms (aCRFs). This role encompasses the specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, as well as the development of Tables, Listings, and Figures (TLFs) and submission packages for various purposes including Data Monitoring Committee (DMC) reviews, Interim Analyses (IAs), and Clinical Study Reports (CSR).
The Senior Biostatistical Programmer will collaborate closely with Biostatistical teams and other departments to deliver high-quality outputs within set timelines and budgets, adhering to applicable International Council for Harmonization (ICH) guidelines, industry standards, regulatory requirements, and Innovaderm's standard operating procedures (SOPs).
Key Responsibilities
- Uphold and advocate for the company's organizational values and expected behaviors, ensuring compliance with SOPs and timely completion of assigned training.
- Serve as the Lead Programmer for multiple individual studies.
- Evaluate the statistical programming scope of work and budget at the start of clinical trials, identifying any out-of-scope tasks.
- Review and contribute to various Data Management documents, Statistical Analysis Plans (SAPs), and TLF Shells.
- Assist Data Management with data cleaning by programming, reporting, reviewing, and resolving statistical data issues in collaboration with other programmers and the Lead Biostatistician.
- Design, maintain, and validate aCRFs in accordance with protocols and Innovaderm's standards, ensuring compliance with Clinical Data Interchange Standards Consortium (CDISC) guidelines.
- Develop and validate specifications and statistical programming for SDTMs, ADaMs, and TLFs based on protocols and standards.
- Create and validate SDTM define.XML/.PDF and associated Reviewer Guides, ensuring adherence to CDISC guidelines.
- Utilize Pinnacle 21 for the validation of SDTMs, ADaMs, and define.XMLs, addressing any discrepancies in collaboration with relevant team members.
- Employ global SAS macros to enhance the efficiency of statistical programming tasks.
- Act as the Unblinded Primary or QC Programmer for randomization plans and lists, IDMCs, and IAs.
- Contribute to the identification of internal initiatives aimed at improving the efficiency and quality of statistical programming deliverables.
- Engage in internal initiatives to enhance statistical programming processes, including the development and validation of standard macros and templates.
- Stay informed about the latest industry standards and guidelines, including CDISC and ICH requirements.
Additional Responsibilities
- Mentor junior Statistical Programmers as needed.
Company Overview
At Innovaderm, we pride ourselves on fostering a collaborative and innovative work environment. Our core values include reliability and responsiveness, and we offer a stimulating atmosphere with ample opportunities for professional growth.
Benefits
- Flexible work schedule
- Remote work options
- Continuous learning and development opportunities
Qualifications
- Bachelor's degree in Statistics, Computing Sciences, or a related field; a Master's degree is an asset.
- A minimum of 7 years of experience in clinical research within the biotechnology, pharmaceutical, or CRO sectors, including 5 years in Statistical Programming and 2 years in a lead role.
Skills and Knowledge
- Strong familiarity with clinical trial data, SAPs, TLF Shells, and specifications.
- Proficient in SAS programming; SAS certification is a plus.
- Knowledge of XML programming is advantageous.
- In-depth understanding of CDISC standards and guidelines; CDISC certification is a plus.
- Comprehensive knowledge of the drug development process, ICH guidelines, and relevant regulatory requirements.
- Highly organized and detail-oriented, with effective project management skills.
- Able to thrive in a fast-paced environment while managing multiple priorities.
- Strong verbal and written communication skills in English.
