Manager/Senior Manager, Statistical Programming, Pulmovant at Pulmovant

Remote, USFull-timeRemoteBiometricsPosted 15 days ago

About the Role

Pulmovant is a Roivant-backed clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases. Pulmovant’s first investigational candidate, mosliciguat, is designed to provide a novel, once-daily, inhaled treatment option for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Mosliciguat is a potential first-in-class soluble guanylate cyclase activator with a differentiated mechanism of action currently being evaluated in the Phase 3 PHrontier global clinical trial in PH-ILD, but with potential broad applicability across the PH and ILD disease landscape.   Pulmovant recently announced positive results from its Phase 2 PHocus study evaluating mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), a progressive and life-threatening condition with significant unmet medical needs for patients. PHocus met both primary and secondary endpoints including the highest ever reported pulmonary vascular resistance (PVR) reduction in any randomized controlled PH trial. The robust results, in conjunction with mosliciguat’s once-daily, inhaled administration and potential first-in-class sGC activator profile, strongly position it as a potential single agent treatment and combination therapy for patients with PH-ILD.  These data represent a significant advancement in a devastating disease that affects ~200,000 patients with no or very limited treatment options. A Phase 3 trial is currently underway. More details can be found in the press release <a href="https://investor.roivant.com/news-releases/news-release-details/roivant-announces-positive-results-phocus-study-mosliciguat">here</a>.  As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress.  For more information, please visit <a href="https://www.pulmovant.com/">https://www.pulmovant.com</a>.  About Roivant:  Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. For more information, visit <a href="http://www.roivant.com/">www.roivant.com</a>.   Position: Manager / Senior Manager, Statistical Programming  Summary:    Pulmovant is seeking a Manager or Senior Manager of Statistical Programming to support the development and delivery of high-quality, submission-ready programming deliverables across our pulmonary/respiratory clinical portfolio. This individual will serve as a lead programmer on clinical studies and regulatory submissions, working closely with Biostatistics, Data Management, Regulatory Affairs, and Clinical Development to ensure that all CDISC-compliant datasets, TLFs, and electronic submission packages meet the highest standards of quality and regulatory compliance.  Key Duties and Responsibilities   <ul> <li data-leveltext="·" data-font="Symbol" data-listid="46" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Develop, validate, and maintain SAS and R programs to produce CDISC-compliant SDTM and ADaM datasets, tables, listings, and figures (TLFs) for clinical studies and regulatory submissions </li> <li>Serve as lead programmer for assigned Phase 2b/3 studies; author and review programming specifications, QC plans, and define.xml files </li> <li data-leveltext="·" data-font="Symbol" data-listid="46" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">Ensure all deliverables are audit-ready and aligned with SAPs, protocols, and applicable FDA/EMA/ICH regulatory guidelines </li> <li>Contribute to the development and maintenance of reusable SAS macro libraries, R packages, and programming standards to improve efficiency and consistency across programs </li> <li data-leveltext="·" data-font="Symbol" data-listid="46" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1">Lead or support statistical programming activities for NDA/BLA/IND submissions, including integrated summaries of safety (ISS) and efficacy (ISE), CSRs, and ad hoc regulatory requests </li> <li>Ensure compliance with CDISC SDTM/ADaM implementation guides, FDA Data Standards Catalog, and eCTD submission requirements; author and review Reviewer's Guides and define.xml </li> <li data-leveltext="·" data-font="Symbol" data-listid="46" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1">Review and provide input on eCRF designs, external data transfer specifications, central lab/imaging specifications, and protocol deviation plans from a programming perspective </li> <li>Represent Statistical Programming at study team meetings; collaborate with Biostatisticians, Data Management, Medical Writing, Clinical Operations, and Regulatory Affairs to align on timelines and deliverables </li> <li data-leveltext="·" data-font="Symbol" data-listid="46" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1">Plan and manage programming timelines and resources across assigned studies; oversee and quality-check deliverables from CROs and external programming vendors </li> <li>Contribute to or lead development of departmental SOPs, work instructions, and process improvement initiatives related to statistical programming </li> <li>Mentor junior statistical programmers; provide technical guidance, code review, and support for professional development </li> <li data-leveltext="·" data-font="Symbol" data-listid="46" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1">At the Senior Manager level, may manage 1–2 direct reports and provide input on hiring, performance, and team-building as the function grows </li> </ul> Education and Experience   <ul> <li data-leveltext="·" data-font="Symbol" data-listid="47" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Bachelor's degree in Statistics, Mathematics, Computer Science, or a related field; Master's degree preferred </li> <li>5–7+ years of statistical programming experience in pharma, biotech, or a CRO (Manager: 5+ years; Senior Manager: 7+ years) </li> <li data-leveltext="·" data-font="Symbol" data-listid="47" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">Advanced proficiency in SAS (Base, Macro, STAT, GRAPH) required </li> <li>Thorough knowledge of CDISC standards (SDTM, ADaM, CDASH) and regulatory submission requirements (FDA eCTD, define.xml, Reviewer's Guides) </li> <li data-leveltext="·" data-font="Symbol" data-listid="47" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1">Proven experience as lead programmer on at least one late-phase (Phase 2b/3) clinical study and/or regulatory submission </li> <li>Strong understanding of GCP, ICH E3/E9 guidelines, and FDA/EMA data submission expectations </li> </ul> Essential Skills and Abilities   <ul> <li data-leveltext="·" data-font="Symbol" data-listid="48" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Excellent attention to detail, communication skills, and ability to manage multiple projects and priorities simultaneously </li> <li>Proficiency in R for statistical programming and reporting; familiarity with Python a plus </li> <li data-leveltext="·" data-font="Symbol" data-listid="48" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">Experience supporting NDA/BLA submissions and responding to health authority queries </li> <li>Familiarity with automation tools, version control (Git), and/or cloud-based programming environments </li> <li>Exposure to real-world evidence (RWE) datasets or adaptive trial designs </li> <li data-leveltext="·" data-font="Symbol" data-listid="48" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1">Experience in pulmonary, respiratory, or rare disease therapeutic areas </li> <li>SAS certification (Base, Advanced, or Clinical Trials Programming) a plus </li> </ul>    Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!

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