Job Category: Pharmaceutical & Biotech

Senior Statistical Programming Manager (DR)

Job Location: San Francisco, CA (see all jobs in CA)

Work Type: Remote

Date Posted: 2022-03-03

Senior Statistical Programming Manager (DR)
San Francisco, CA (Remote)

Responsible for developing program specifications, programming datasets, TLFs, and providing other statistical programming support for assigned clinical program(s). The position requires a broad, comprehensive, and detailed knowledge of programming languages and software, filing requirements, clinical trial databases, and pharmaceutical drug development process. The incumbent will lead/develop programs that generate CDISC compliant ADaM datasets, TLFs and a variety of reports to facilitate the review of clinical data & validate such programs, write general SAS application codes, prepare documentation for electronic submissions, and explore new technologies to enhance quality and productivity of analytical programming group. You will also contribute to departmental process and standards initiatives.

Do you want to apply your existing technical skills, join a high-performing team and learn and implement new capabilities? Can you see yourself playing a key role in clinical development and trial design for our antibody therapeutics? If so, we want to hear from you.

During your first year, your goals will include:
Provide statistical programming support and lead programming related activities for the analysis and reporting process including, but not limited to, Clinical Study Report development, regulatory submissions, and the scientific utilization of our data at clinical programs as well as individual study level. Lead/contribute to the delivery of the Clinical Study Report, Analysis Data Model datasets and Tables, Figures and Listings through both internal and external delivery models. Lead/contribute to the statistical programming deliverables for regulatory submissions e.g. define.xml & Reviewers Guide, and delivery of outputs in response to regulatory questions. Lead/contribute to the development of best practice to improve quality, efficiency and effectiveness of programming group activities. Lead/contribute to the delivery of Safety Update Reports, Periodic Benefit-Risk Evaluation Report, Investigators brochures. Plan and execute the transfer and analysis of data for safety/efficacy monitoring boards/independent data monitoring committees as needed. Lead/contribute to the oversight of deliverables provided by CROs. Produce and maintain programming specification documents. Follow the department and company standard operating procedures (SOPs), policies, and standards. Provide feedback on these guidelines as needed. Mentor and train junior programmers or other team members and/or develop training materials as needed. Represent analytical programming group at various forums such as study team meetings & department initiatives.

REQUIREMENTS:
Bachelor’s degree in any Science field-, such as Biology, Physics - Chemistry - Computer Sciences and Computer Engineering, other Engineering fields, Mathematics, Economics, or other quantitative field with a minimum of 8 years statistical programming and analysis using SAS programming language in the pharmaceutical or biotechnology industry. Prior neuroscience & oncology experience highly desirable. Dynamic self-starter, agile learner, strategic and creative problem solver. Demonstrated strong decision-making and risk-mitigation skills while managing concurrent projects and activities. Requires solid knowledge of statistical programming principles, clinical trials process and regulatory requirements. Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment and ability to influence stakeholders. Able to communicate and collaborate effectively with cross-functional teams (Clinical Operations, Scientists, Medical Monitors and Statisticians) in face-to-face conversation, by telephone, and by email. Good working knowledge of ICH, FDA, and GCP regulations and guidelines. Strong well-rounded technical skills (SAS, EDC systems, MS Word, Excel, PowerPoint, API based data extracts, ETL principles) and knowledge of industry standards (CDISC, SDTM, CDASH, ADaM). Prior experience working with data visualization software such as Spotfire, Tableau, Saama is desirable. Consistent track record to work both independently and in a team setting in a leadership role.

Please contact Derek Reilly at dreilly@clarkdavis.com

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