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Associate Director/Director, Lead Statistical Programmer
3 months ago
The incumbent will translate statistical objectives into relevant work products, establish programming strategies and ensure quality execution. The position will be a combination of conducting complex programming, developing programming plans and contributing to regulatory documents. In addition to hands-on work, the incumbent will coordinate with other biostatisticians/programmers on execution of other statistical deliverables
Position Responsibilities:
- Develop programming specifications based on translating Statistical Analysis Plans that can be used by either internal or external CRO partners to prepare validated programming in support of R&D objectives.
- Prepare and/or review CDISC (SDTM and AdAM) data specifications to ensure regulatory acceptability of Madrigal’s clinical trial data bases.
- Develop and/or oversee development of tabular and graphical representations data that enable effective interpretation of clinical trial data.
- Develop complex programs in either R or SAS that enable timely assessment of critical data analyses.
- Collaborate with study teams and functional management in defining. Enables the successful transition from programming deliverables into CSRs and other regulatory documents.
- Ensures programming documentation and QC of programmed outputs are completed and filed appropriately.
- Perform holistic review of aggregated clinical, quality and performance data and proactively address quality or performance issues jointly with the study teams in line with issue management and risk-based quality management processes.
- Contribute to process improvement and development of efficient procedures for Clinical Data Review and other cross-functional data quality-related initiatives.
- May manage less senior data analysts/programmers.
Qualifications and Skills Required:
- Bachelor's degree in mathematics, computer science, data science, statistics or related life science field (Master’s degree preferred).
- At least 5 years of experience in the pharmaceutical/biotech industry with prior regulatory submission experience (7 years for a Director)
- Experienced in SAS and R programming.
- Understanding of regulatory guidance ( e.g. ICH, GCP).
- Experience in CDISC data standards, medical terminology and quality control practices.
- Excellent understanding of and experience in all aspects of data cleaning procedures.
- Prior experience with overseeing programming delivered by a CRO partner.
- Expert in techniques and processes used to validate programming and documentation requirements.
Compensation:
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.
Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.
Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.
Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.
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