#976 - Biostatistician-II
Venon Solutions · Miami, NM
- On site
- Full-time
- $100,000 / year
- Miami, NM
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Job highlights
- Remote Biostatistician II role.
- Support clinical trials and submissions.
- Requires 2-3 years pharma experience.
- Must know SAS and CDISC standards.
- Collaborate with cross-functional teams.
About the role
Biostatistician II
We're seeking an experienced Biostatistician-II to support our client's clinical development programs within the Biometrics organization. This role is intended for a biostatistician with 2–3 years of pharmaceutical industry experience who can independently support statistical activities for clinical trials and contribute meaningfully to regulatory submissions and inspection readiness. The Biostatistician-II will serve as a key statistical partner to cross-functional teams, ensuring high-quality, compliant, and submission-ready analyses that support clinical and regulatory decision-making.
Requirements
- Advanced English level (B2/C1/C2) to ensure fluent communication across teams.
- 2–3 years of statistical programming experience within a pharmaceutical, biotechnology, or clinical research organization.
- Strong hands-on experience with SAS for clinical trial programming; working knowledge of R preferred.
- Solid understanding of clinical trial data structures and end-to-end development processes.
- Working knowledge of CDISC standards, including ADaM; familiarity with SDTM required.
- Understanding of regulatory expectations for statistical programming, including documentation, traceability, and inspection readiness.
- Demonstrated ability to manage multiple deliverables independently while meeting timelines and quality expectations.
- Strong analytical, problem-solving, and troubleshooting skills.
- Effective written and verbal communication skills, with the ability to collaborate across cross-functional teams.
- High attention to detail, strong documentation practices, and commitment to quality and compliance.
Responsibilities
- Serve as the primary statistical support for assigned clinical studies or components of larger development programs
- Provide statistical input into clinical trial design, including endpoints, estimands, analysis populations, and statistical methodologies
- Author, review, and maintain regulatory-critical statistical documents, including: Statistical Analysis Plans (SAPs), Tables, Listings, and Figures (TLFs) shells and outputs, and Statistical sections of Clinical Study Reports (CSRs).
- Oversee and/or validate statistical analyses performed by statistical programmers, ensuring alignment with approved SAPs and regulatory expectations.
- Ensure all statistical deliverables are submission-ready, traceable, and inspection-ready, in compliance with internal SOPs, ICH guidelines, and FDA/EMA requirements.
- Participate in ongoing data review and data monitoring activities, proactively identifying data trends, anomalies, and risks to study integrity.
- Collaborate cross-functionally with Clinical Development, Data Management, Programming, Medical Writing, and Regulatory Affairs to deliver integrated, high-quality outputs.
- Support preparation and review of regulatory submission materials (e.g., NDA, BLA, MAA), including datasets, analysis outputs, and documentation.
- Contribute responses to health authority questions, audits, and inspections by providing statistical analyses, justifications, and supporting documentation.
- Maintain comprehensive statistical documentation to support audit trails, reproducibility, and long-term data archival.
- Contribute to the continuous improvement of biometrics standards, processes, templates, and best practices.
- May provide informal guidance or mentoring to junior biostatisticians.
What do we offer?
- 100% Remote work.
- Competitive salary in USD.
- Type of contract: Independent Contractor with Venon Solutions LLC.
- Contract duration: Long-term.
- 2 weeks of PTO (paid time off).
- Paid Holidays: from the Client's calendar (USA)
- Working hours: Full-time EST timezone, fully committed.
Key skills/competency
- Biostatistician
- Statistical Analysis Plans (SAPs)
- SAS programming
- Clinical trials
- Regulatory submissions
- CDISC standards
- Data analysis
- Pharmaceutical industry
- ICH guidelines
- Biometrics
Skills & topics
- Biostatistician
- Biostatistician II
- SAS
- R
- Statistical Programming
- Clinical Trials
- Pharmaceutical
- Biotechnology
- CDISC
- ADaM
- SDTM
- SAPs
- TLFs
- CSRs
- ICH Guidelines
- FDA
- EMA
- Biometrics
- Regulatory Submissions
- Remote
- Latin America
How to get hired
- Tailor your resume: Highlight SAS programming, CDISC, and 2-3 years of pharmaceutical experience.
- Showcase your skills: Emphasize experience with SAPs, TLFs, and regulatory submissions.
- Demonstrate communication: Prepare examples of cross-functional collaboration and problem-solving.
- Understand regulatory context: Be ready to discuss ICH guidelines and inspection readiness.
- Highlight remote work skills: Showcase independence and time management for remote success.
Technical preparation
Master SAS programming for clinical trials.,Review CDISC ADaM and SDTM standards.,Practice writing Statistical Analysis Plans.,Familiarize with regulatory submission documentation.
Behavioral questions
Describe managing multiple project timelines.,How do you ensure data quality and compliance?,Give an example of cross-functional collaboration.,How do you handle complex problem-solving?
Frequently asked questions
- What is the work arrangement for the Biostatistician II role at Venon Solutions?
- The Biostatistician II position at Venon Solutions offers a 100% remote work arrangement, allowing you to work from anywhere within Latin America.
- What level of English proficiency is required for the Biostatistician II job?
- An advanced English level, specifically B2, C1, or C2, is required to ensure fluent communication with cross-functional teams.
- What are the primary statistical software requirements for this Biostatistician II position?
- Strong hands-on experience with SAS for clinical trial programming is essential. A working knowledge of R is also preferred for this role.
- What is the expected experience level for the Biostatistician II role?
- The ideal candidate for the Biostatistician II position will have 2-3 years of statistical programming experience within the pharmaceutical, biotechnology, or clinical research organization sector.
- What are the key responsibilities of a Biostatistician II at Venon Solutions?
- Key responsibilities include providing statistical support for clinical studies, authoring statistical documents, overseeing analyses, ensuring submission-readiness, and collaborating with cross-functional teams.
- What specific CDISC standards are important for this Biostatistician II role?
- A working knowledge of CDISC standards, including ADaM, is required. Familiarity with SDTM is also necessary for this Biostatistician II position.
- What kind of contract is offered for the Biostatistician II position?
- This is an Independent Contractor role with Venon Solutions LLC, offered on a long-term basis.
- Does this Biostatistician II role involve client interaction or only internal team collaboration?
- The Biostatistician II role involves serving as a key statistical partner to cross-functional teams within the client's organization, requiring collaboration both internally and externally with regulatory bodies.