Director, Statistical Programming
$239k - $308kCSL Plasma
## Director, Statistical ProgrammingPresenta candidaturalocations: Americas, US-PA, King of Prussia, CSL Behring: EMEA, GB, Berkshire, Maidenhead, CSL Behring: Americas, US-MA, Waltham, CSL Behring: EMEA, CH, Glattbrugg, CSL Behringtime type: Full timeposted on: Offerta pubblicata oggijob requisition id: R-276156The Director, Statistical Programming provides leadership and expertise in driving the development and maintenance of the CSL statistical programming capabilities which is required to meet regulatory obligations. Manages a team of programmers supporting clinical trial and integrated analyses, annual reporting, regulatory responses, publications, HTA requests and other purposes as needed within one or more therapeutic areas.The individual will work closely with the Senior Director, Clinical and Statistical Programming to advance the internal programming environment and statistical programming processes. Works closely with Statisticians to ensure that deliverables provided by internal resources or outside providers (CROs; FSP providers) are accurate and aligned with CSL standards. Reporting Relationships: List other positions in the company that are reporting into this position or that this position reports into.**Main Responsibilities and Accountabilities:*** Working with the Biometrics Programming Leadership team, assess upcoming activities and resulting resource needs and allocate projects to people to ensure high quality, timely, delivery. Ensure realistic resource planning.* Oversee the CRO delivery or manage the in-house programming of data sets, outputs, and DDT files of clinical trials and integrated analysis.* Coordinating the oversight or in-house programming of exploratory analyses, analyses to support secondary publications, response to regulatory requests, or other ad-hoc requests.* Manages, hires, and mentors direct reports including annual evaluations and goal setting.* As a member of the programming leadership team within biometrics, creates, maintains ensures compliance with programming process and strategy to facilitate accurate and timely analysis programming.* Help bring state of the art programming methods and tools to the organization and drive automation of delivery, including AI.* Collaborate with Biometrics and other departments to ensure transition points in process are efficient and of high quality.* Represents the company in outside professional organizations and meetings.**Job Qualifications and Experience Requirements:****Education:**• BSc in Computer Science, Mathematics, Statistics or related area with relevant experience• Other degrees and certifications considered if commensurate with related programming experience.**Experience:**• At least 10 years of experience in the biotech, pharma, or CRO industries • Preferred 5 or more years of direct supervisory experience • Experience with CRO management and/or CRO work experience • Extensive understanding of clinical programming and/or statistical programming processes and standards • Advanced Experiences with statistical programming using the SAS software including development and use of SAS Macros, preferred managing team performing these activities as well • Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM) • Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines • Experience in working in cross-functional, multicultural and international clinical trial teams **Competencies**• Coding in SAS, including SAS macro language • Interest and/or experience in expanding beyond SAS as the primary programming delivery tool • Experience in and passion for automatization of routine programming tasks • Broad knowledge of clinical development and processes • Strong interpersonal and communication skills (verbal and written in English), comfortable around senior management • Ability to collaboratively work and provide leadership in matrix environment • A solutions oriented mindset • Fluency in technical requirements for CDISC compatible datasets and DDT files • Presentations of programming techniques at professional conferences is a plus***The expected base salary range for this position at hiring is $239,000 - $308,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the Waltham, MA location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity*** #J-18808-Ljbffr
$175k - $204k
...the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic... ...individuals, families and communities.Role Summary:The Associate Director, Statistical Programming is accountable for program-specific and cross-study...SuggestedLocal area$171.5k - $214.42k
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...underserved therapeutic areas and make patients the focus of every strategic decision. Job DescriptionRole SummaryThe Associate Director, Statistical Programming leads statistical programming activities for multiple studies, an asset or an indication by performing hands-on...SuggestedTemporary workFor contractorsLocal areaRemote workFlexible hours$181.1k - $244.9k
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...Associate Director, Statistics Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to... ...Translational Sciences, Statistics & Quantitative Sciences, Programming, Patient Safety & Pharmacovigilance, and Strategic...Minimum wageFull timeTemporary workWork at officeLocal areaRemote work$239.89k - $290.69k
A leading biopharma company based in Cambridge, MA, is seeking a Director of Statistical Genetics. The candidate will drive computational strategies to infer causal mechanisms of diseases, manage cross-biobank analyses, and coordinate the evaluation of novel drug targets...$150.5k - $245.5k
...science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Statistical Programming to join our Statistical Programming function, providing technical leadership across project teams within one or more...Worldwide$150.5k - $245.5k
.... Manager provides timely support to the project team on all programming matters according to the project strategies within a therapeutic... .... Project requirements will be identified according to a Statistical Analysis Plan, programming specifications or user requirements...Local area$128.6k - $210k
...A Manager Statistical Programming provides timely support to the study team on all programming matters according to the project strategies. As an integral part of a study team, the incumbent provides project leadership and programming support for processing data from...Permanent employmentFor contractorsWork experience placementLocal area$156k - $185k
...global manufacturing capacity. Xometry is seeking a Staff Technical Program Manager to lead our high‑stakes, multi‑phase partnership with... .... TPM Leadership: Serve as a senior thought partner to the Director of Technology Operations. Help codify TPM best practices, mentor...Work at office3 days per week$179k - $212k
...worldwide. Could you be our next Associate Director, Clinical Assay Strategy-Flu? The job is... ...assays supporting clinical development programs. This is a strategic, non-laboratory-... ...Development, Regulatory Affairs, Statistics, and CMC teams. Translate immunological...Work at officeWorldwide3 days per week$178k - $215k
Boston Dynamics is adding a Principal Technical Program Manager - Actuators to our Atlas Program Management Team.As the Lead Actuation Technical Program Manager for a new product team you will help coordinate the development lifecycle of robotics actuators from early stage...Full timeVisa sponsorshipAfternoon shift- ...vaccine provider. This role is the Associate Director for Clinical Assay Strategy – Flu, based... ...assays supporting clinical development programs. Design, validate, and standardize... ...Clinical Development, Regulatory Affairs, Statistics, and CMC teams to translate immunological...3 days per week
- ...and teaching. Our 70+ faculty are leaders in the development of statistical methods for clinical trials and observational studies, studies... ...computational biology, and genomics/genetics. We offer degree programs in biostatistics, computational biology and data science;...TraineeshipWork at officeWorldwideShift workAfternoon shiftEarly shift
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$103.6k - $162.8k
...Enablement, Operations, and Customer Experience, ensuring coordinated execution and measurable adoption across a portfolio of GTM programs. Product launches will be a core and recurring part of this portfolio, so direct experience leading product release programs is essential...Live inWorldwideShift work$115k
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...leading manufacturing expertise to develop advanced therapies faster and more efficiently.The Role:The Manager, CMC Operations and Program Management will lead the cross-functional activities between CMC groups and other departments at ElevateBio BaseCamp including process...2 days per week3 days per week$207.65k
...and X. Employer: Analog Devices, Inc. Job Title: Technical Program Manager Job Requisition: 1010.146 / R264727 Job Location: Boston... ...Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. As such, applicants for this...Permanent employmentFull timeContract workWork at officeRemote workWork from homeShift workDay shift2 days per week- ...with serious and rare diseases, and we are getting closer to achieving this goal every day.Reporting to the Program Lead for the TED portfolio, the Associate Director, Program Management will support the coordination and planning of programs of meaningful scope and...Temporary workWork at officeLocal areaImmediate start3 days per week
$227k - $283.79k
...Multiple Sclerosis (MS). Zenas’ earlier stage programs include ZB021, a clinical-stage,... ...Innovation!Position Summary:The Senior Director, Biomarker Development, Strategy, and Operations... ...of biomarkers into clinical protocols, statistical analysis plans, and regulatory...
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