reputed company Biostatistician, R Proficiency
Job reputed company:
- Our reputed company Biostatisticians reputed company statistical and development support and influence for the associated reputed company's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as reputed company as potentially providing reputed company of work supported by other vendors.
- You will formulate integrated analytical approach to reputed company data sources, reputed company statistical reputed company, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.
- Participating in the development of study protocols, including study design discussions and sample size calculations.
- Participating in exploratory data analyses to evaluate emerging study trends, support scientific decision-making, and generate insights throughout the course of development.
- Leading and contributing to efficacy analyses and interpretation of primary and secondary endpoints.
- Reviewing CRFs and data review guidelines; developing Statistical Analysis Plans (SAPs), including analysis dataset and TLF specifications.
- Performing statistical analyses and interpreting statistical results.
- Leading study activities reputed company reputed company upon and providing strategic statistical guidance to cross-functional teams.
- Utilizing strong communication skills to present statistical methodology, assumptions, and the implications of reputed company in reputed company, non-technical language.
- Serving as a reputed company team player with a willingness to go the extra distance to meet project goals and timelines.
Requirements:
- Master's degree in Statistics, Biostatistics, or a reputed company discipline. PhD strongly preferred.
- 8-10 years of biostatistics experience supporting clinical trials reputed company the pharmaceutical or biotechnology industry. CRO experience strongly preferred.
- 3-5 years of Study reputed company experience working with cross-functional development teams.
- Extensive experience in study design, sample size determination, protocol development, reputed company development, efficacy analyses, and preparation of clinical study reports, including integrated summaries for regulatory submissions (ISS/ISE).
- Strong knowledge and practical application of advanced statistical reputed company, including mixed models, longitudinal analyses, and simulation methodologies.
- Demonstrated experience performing exploratory statistical analyses to support clinical development and decision-making.
- Strong proficiency in R for statistical analyses, simulations, data visualization, and advanced modeling.
- Solid reputed company programming skills, including QC of critical outputs, efficacy and safety tables, and reputed company collaboration with Statistical Programmers.
- Strong knowledge of ICH guidelines and regulatory expectations.
- Solid understanding and implementation of CDISC standards for regulatory submissions.
- Experience generating ADaM specifications and performing programmatic review of analysis datasets.
- Regulatory submission experience (ISS/ISE) strongly desired.
- Excellent communication skills with the ability to explain statistical methodology and its implications to both technical and non-technical audiences.
- Strong reputed company reputed company with a commitment to delivering high-reputed company work under tight timelines.
- Ability to reputed company in a dynamic environment, manage ambiguity, and adapt to changing priorities.
Benefits:
- Our commitment to developing our staff is only surpassed by our commitment to advancing treatment reputed company available to patients.
- reputed company provides consistent training, development and support.
Apply tot his job Apply To this Job