Advanced Clinical is currently recruiting on the behalf of a mid-size pharmaceutical company based in South San Francisco, CA. We are seeking an experienced Senior Manager of Statistical Programming candidate. This is a clinical-stage company with a broad portfolio of therapeutics in areas such as orphan and rare diseases. The organization offers a great salary, bonus, benefits, stability, and opportunities for career progression. Currently, the entire company works from home (WFH), but when it opens again, you'll typically be allowed 2-3 days WFH and flex on time/schedule.
Day-to-day responsibilities include:
Manage all aspects of study deliverables related to statistical and clinical programming for multiple studies as the technical lead and project manager
Support the programming for Clinical Study Report (CSR), Integrated Summaries of Safety (ISS), and Integrated Summaries of Efficacy (ISE) submissions
Generate/review the CDISC SDTM and ADaM files and specifications, SAS export files, and Define.xml use for Electronic Submission provided by CROs
Review Data Management Plan, Data validation plan, and edit check specifications
Interact with biostatisticians and other clinical team members
Essential skills and requirements include:
Minimum of 8 years of Pharmaceutical/Biotech programming experiences required
Detailed knowledge and extensive hands-on experience of CDISC methodologies
Expert level experience in writing CDSIC standard dataset specifications and following specifications to create SDTM and ADAM datasets
Strong SAS programming and management background
Excellent knowledge and experience of SAS Programming languages including SAS Base, SAS/Macros, SAS/Graph, and SAS/Stat
Education
Minimum of Bachelor's Degree required
Master's Degree in Statistics, Mathematics with 5 years of experience preferred
To be a best-fit your strengths must include:
Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
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