Manager, Statistical Programming

🕒 il y a 1 mois

❄️ Minnesota – Distant

❄️ Minnesota – Remote

💵 $160 000 - $185 000 / an

⏰ Temps Plein

🟠 Senior

🔴 Expert

👔 Manager

👻 Score fantôme 2%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Celcuity

Site WebLinkedInTous les Emplois

51 - 200 employés

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

Healthcare • Biotechnology • Pharmaceuticals

Celcuity est une entreprise de biotechnologie en phase clinique développant des thérapies ciblées qui bloquent la voie PI3K/AKT/mTOR (PAM) pour traiter plusieurs tumeurs solides. Son principal candidat, le gedatolisib, est un inhibiteur potentiel de première classe pan-PI3K et mTORC1/2 en cours d'évaluation dans des essais sur le cancer du sein et de la prostate. L'entreprise avance un pipeline ciblé visant à offrir des traitements contre le cancer transformateurs et ciblés et mène un développement clinique et une recherche basée sur les données pour soutenir l'adoption réglementaire et médicale.

Description

• Oversee statistical programming activities for assigned projects from study planning through database lock, reporting, and regulatory submission • Provide technical leadership and statistical programming expertise for timely, high-quality, compliant clinical trial programming deliverables • Contribute to departmental SOPs, programming standards, templates, processes, and continuous improvement initiatives • Develop and maintain reusable programming tools, macros, and automation solutions • Support resource planning and prioritization across assigned studies • Provide technical guidance, mentoring, and knowledge sharing to statistical programmers • Represent Statistical Programming in study team meetings throughout the clinical development lifecycle • Lead and oversee programming for SDTM, ADaM, and Tables, Listings, and Figures (TLFs) • Develop, review, and oversee SAS programs for clinical study deliverables, analysis datasets, and reporting outputs • Review programming specifications, dataset documentation, validation results, and final deliverables • Support regulatory submissions, including SDTM/ADaM datasets, Define-XML, annotated CRF, cSDRG, ADRG, and related documentation • Support clinical publications, abstracts, posters, manuscripts, and external scientific communications • Support ad hoc and exploratory analyses, data requests, and real-world evidence initiatives • Coordinate and supervise CRO and external service-provider programming activities • Monitor progress and identify risks, issues, and mitigation opportunities • Review clinical data outputs and programming results for accuracy, completeness, and compliance • Provide technical support to resolve complex programming issues • Collaborate with Biostatistics, Clinical Development, Data Management, Regulatory Affairs, Medical Writing, and CRO/vendor partners

🎯 Exigences

• Minimum of eight (8) years of statistical programming experience within the pharmaceutical, biotechnology, CRO, or healthcare industry • Strong proficiency in SAS programming within clinical trial environment • Strong knowledge and practical experience with CDISC standards, including SDTM and ADaM • Experience developing, reviewing, and validating clinical trial datasets and Tables, Listings, and Figures (TLFs) • Experience supporting clinical studies from study start-up through database lock, reporting, and regulatory submission • Knowledge of regulatory submission requirements and experience supporting submissions to health authorities such as FDA, EMA, or PMDA • Experience with clinical trial programming documentation, validation processes, and quality control practices • Demonstrated ability to manage multiple priorities while maintaining strong attention to detail and quality • Excellent verbal, written, and interpersonal skills, with the ability to communicate effectively and collaborate with cross-functional teams in a remote/global environment • CRO/vendor oversight experience preferred • Experience with Pinnacle 21 or similar CDISC validation tools preferred • Experience with SAS macros, automation, and programming efficiency initiatives preferred • Experience with R, Python, or other programming technologies preferred

🏖️ Avantages

• Annual performance incentive bonus • New hire equity package • Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays