Principal Clinical/Statistical Programmer- (Remote)
Principal Clinical Statistical Programmer
Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
We are seeking to recruit a Principal Scientist for the Clinical Data Science / Statistical Programming Group with experience supporting drug development, medical device, or clinical study projects; and has excellent statistical programming and problem-solving skills to support our clinical development programs. The ideal candidate will be able to function as a leader and individual contributor, will take the initiative to stay current on technologies and methods, come up with innovative solutions to challenging problems, and work with Biometrics management to help set the overall strategic direction of the group. As a member of the Biometrics team at Denali Therapeutics, the candidate will work closely with clinical study team members and biometrics colleagues. The candidate will have the opportunity to help shape Denali’s data and programming infrastructure, gain an in-depth understanding of drug development in a fast-moving industry environment and subject domain knowledge in the field of neurodegeneration.
- Represent data science on study execution teams. Study execution support will include creation of datasets, data visualizations or summary reports to support internal decision making and regulatory interactions (IND/CTA filings, annual safety reporting, etc.).
- Providing input for study data standardization plan, study protocols, statistical analysis plans, randomization specifications, and clinical study reports.
- Partner with Clinical Data Management to provide input for case report form design, data review plans, and external data transfer specifications.
- Collaborate with study team and external functions (e.g., CROs, specialty lab vendors, clinical development partners, etc) to ensure meeting project timelines and goals
- Provide technical leadership in designing, developing, and validating of clinical trial data for regulatory submissions in CDISC (SDTM, ADaM, Define.xml, SDRG, ADRG, aCRF and P21 checks, etc..) format
- Develop and manage reusable code for interactive data visualization and analytics tools for reporting and exploratory analysis.
- Lead and/or support the biometrics team in efforts to build, maintain, and continuously improve an SAS/R infrastructure that is suitable for regulatory submission work.
- Curate tidy analysis data for use with statistical reporting code and analytics applications.
- Provide programming support to prepare regulatory requested analyses and help submission team in quick turnaround in response to regulatory agencies.
- Perform programmatic review of analysis datasets and TLFs generated by programming teams, ensure high quality of deliverables, conduct Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS)
- Work with the biometrics team to establish innovative processes to ensure high data quality, reporting of analysis results, and analysis reproducibility.
- Support data science and biometric functional initiatives. Lead/participate in departmental or cross-functional working groups and process improvement activities.
- Effectively interact with external programming resources, including contributing to development and/or review of contract specifications and feedback on performance.
- Act as mentor and train data scientists/statistical programmers regarding programming techniques, project management, and implementation of standards.
- Contribute to the recruitment and retention of both permanent and contract talent.
Must Have Qualifications
- At a minimum, a bachelor’s degree in Statistics, Biostatistics, Data Science, Mathematics, or related field.
- 8+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies.
- Thorough understanding of the clinical drug development process (clinical trials Phase I-IV).
- Prior direct report management experience including mentoring, training, and enabling staff to grow professionally.
- Extensive applied experience with SDTM and ADaM CDISC data standards and health authority submission of data; or familiarity and exposure to CDISC standards (i.e., SDTM, ADaM) for regulatory submissions and willingness to become a subject matter expert in applying these standards.
- Knowledge of regulatory requirements concerning electronic submission standards and experience in delivering one or more submissions to regulatory authorities globally.
- In depth knowledge of statistical programming languages such as SAS (including Base, STAT, Macro and GRAPH), R (including tidyverse, RMarkdown, Shiny, htmlwidgets, development of R packages), and common technology platforms
- Demonstrated experience in creating compelling data visualizations to help teams make correct data driven decisions and effectively communicating results to team members.
- Able to demonstrate a solid understanding of statistical principles and methods used in clinical study reports or scientific publication analyses.
- Experience applying software development concepts, and proficiency in using Git/GitHub for collaboration and versioning of operational, robust, and well documented code.
- Demonstrated ability to effectively lead projects and collaborate cross-functionally.
- Able to work in a Linux/Unix environment (including shell scripting).
- Working knowledge of relevant FDA, EMA, PMDA, HC and ICH guidelines and regulations.
- Prior work experience with pharmacokinetic data and the neuroscience field,
- proficiency in languages or tools other than SAS (e.g., R, Python, and Java, Shiny, Markdown, Unix/Linux, and git),
- Experience with Amazon Web Services and cloud infrastructure, and experience with applying machine learning techniques.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
Salary Range: $167,000 to $203,667. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
*This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
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