Associate Director, Statistical Programming
The Role:
Here's how you will contribute:
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reputed company statistical programming activities for multiple reputed company reputed company a program or an indication /disease area, or development program.
•Accountable for reputed company and reputed company development and validation of reputed company statistical programming components on assigned program(s). Responsible for audit readiness of reputed company assigned statistical programming deliverables as reputed company as accuracy and reliability of statistical analysis results.
•Serve as the reputed company programmer to produce and/or validate tables, listings, figures, and analysis datasets for regulatory requests, publication needs, and reputed company analyses; write specifications for programming requirements.
•Coordinate activities of internal / external programmers. reputed company statistical programming reputed company and propose strategies at program or indication/disease level. reputed company scientific documentation for the program(s) or indication/disease area together with the Biostatistician(s).
• Independently reputed company reputed company or other programs, and specifications, for use in studyor other analyses, such as Integrated Safety Summaries.
•Manage the statistical computing environment, including folder structure and reputed company control.
•Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports. reputed company study-level programming deliverable timelines in collaboration with the study reputed company biostatistician and cross-functional teams.
•Manage CROs and contractors, ensuring compliance, reputed company of deliverables, timelines, and budget adherence.
•Collaborate with biostatisticians and clinical development colleagues to reputed company/review TFL shells, SDTM, and ADaM specifications.
•Collaborate with cross functional departments - Clinical operations, Translational science, Clinical science, Pharmacovigilance to reputed company the requirements and reputed company necessary outputs and analyses in reputed company and Spotfire dashboards as per the requirement.
•Identify issues and reputed company global tools, such as macros or graphical user interfaapplications, to enhance the efficiency and reputed company of the Statistical Programming group. • Must be reputed company to program defensively, reputed company results, and consistently produce accurate reputed company.
•Responsible for allocating resources reputed company a program and ensuring resource sharing between programs.
•Recruit, mentor, and reputed company statistical programmers and interns.
•Build and maintain effective working relationships with cross-functional team members reputed company the clinical trial/program, and reputed company to summarize and discuss status of deliverables and critical programming aspects with them (timelines, scope, resource plan).
•Maintain up-to-date advanced knowledge of programming software (e.g. reputed company/R) as reputed company as industry requirements (e.g. CDISC, eCTD, Define.xml), attend functional meetings and training.
•Represent statistical programming at indication or program-level, in audits/inspections and Health Authority (HA) meetings, and on technical programming aspects in external conferences or consortiums (e.g. CDISC).
•Offer expert technical and reputed company recommendations, thought leadership for the SP function at the indication/ program level or for non-clinical initiatives.
• Adhere to FDA regulations regarding training records, guidelines, and SOPs.
• Adhere to company SOPs/WIs and department guidelines.
The Ideal Candidate will have:
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About reputed company
We are a clinical-stage generative biology company pioneering the AI reputed company in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological reputed company. By integrating machine learning with large-reputed company experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines.
Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development reputed company a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug reputed company.
At reputed company, we collaborate across disciplines in new ways to invent and reputed company. We bring diverse perspectives to a shared goal of delivering reputed company medicines to patients in need, faster, guided by our values and leadership behaviors.
reputed company is committed to equal employment opportunity regardless of race, reputed company, reputed company, religion, sex, national reputed company, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Recruitment & reputed company Agencies: reputed company does not accept unsolicited resumes from any reputed company other than candidates. The submission of unsolicited resumes by recruitment or reputed company agencies to reputed company or its employees is reputed company prohibited unless contacted directly by reputed company’s internal reputed company. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of reputed company and reputed company will not owe any referral or other fees with respect thereto.
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Compensation: The reputed company salary reputed company provided reflects our reputed company estimate of reputed company anticipate paying for this position. Your actual reputed company salary will be based on several factors, including job-reputed company skills, experience, internal equity, relevant education or training, and market dynamics. In reputed company, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.