Senior Clinical Data Programmer

Acceleron Pharma

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 05/28/2021
  • Website: acceleronpharma.com
  • Company Address: 128 Sidney Street, Cambridge, MA, 02139

About Acceleron Pharma

Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. The Company's leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair.

Job Description

As a member of our Data Management and Clinical Operations team, you will support clinical trial activities from a programming perspective across a study or group of studies under one or more programs. 

With support and guidance from the study team, you will manage Spotfire and SAS programming/Development activities. Your expertise will be used to develop customized, programmed data listings and data reports/visualizations to improve clinical data quality and process efficiency.  You will manage incoming clinical data from our clinical vendors and ensure data is received and processed according to Acceleron SOPs, data transfer specifications and study requirements.  You may also have the opportunity to be involved with clinical database setup/modification activities (design, build/programming, validation, finalization) as needed.

*note: this position is based within our Cambridge, MA headquarters .  We are not able to consider remote candidates outside of the Greater Boston area. 

 What will you be doing?

  • Lead clinical programming activities across one or more studies for the DM and CO functional areas and liaise with our biostatisticians to understand final requirements and structure of study data being presented
  • Initiate, lead, maintain and ensure finalization of clinical programming activities during the startup, maintenance, and closeout phases of one or more assigned clinical studies
  • Ensuring clinical programming activities are documented and filed accordingly in appropriate sections of the clinical study file documentation
  • Work with DM and CO to draft and finalize custom report programming specifications required to program customized data listings, patient profiles, data displays and metrics reporting of clinical trial data
  • Review and provide feedback of clinical data management study documents including Case Report Forms (CRFs), CRF Completion Instructions, Data Management Plan (DMP), Database Specifications, Electronic Edit Checks, Manual Data Listings Review Plan and Data Transfer Specifications
  • Maintenance and development of simple to complex Spotfire dashboards
  • Visualization development
  • Configure visualization properties to limit, display, color, and mark items as desired
  • Write custom expressions to limit data and set cross-table axis values, among other things
  • Debug visualizations to determine if any noted defects exist within the visualization itself or within data it is receiving.
  • Review or create materials, presentations, and/or tools to support department's remit and strategies.
  • Proactively collaborate with initiative leads and senior management to develop, optimize and improve processes, associated systems/applications, training, and communications
  • Develop, validate, and maintain SAS programs and macros required across studies
  • Develop, validate, and maintain Spotfire outputs and visualizations required for ongoing manual data reviews by the Acceleron clinical study team
  • Proactively organize internal study meetings with clinical operations or data management leads as required to understand data sources needed per the report specifications and understand the intent of programmed tools being developed to support the study

What are we looking for?

  • Bachelor’s degree and minimum of 5 years of professional work experience at a biopharmaceutical company or clinical research organization utilizing TIBCO Spotfire to create  data displays, outputs, and visualizations.
  • Demonstrated expertise in TIBCO Spotfire analysis, design, and development required; SAS programming highly preferred.
  • Strong reporting and dashboard experience
  • Ability to provide Spotfire upgrades, maintenance, and optimization.
  • Ability to translate business needs and priorities into processes and systems requirements.
  • Industry knowledge of biopharmaceutical organizations including pharmacovigilance, Clinical Operations, and/or Clinical Data Management.
  • Strong knowledge of PV regulations, systems, and processes as related to Spotfire.
  • Previous experience supporting clinical trials from a SAS programming perspective and understanding of SAS programming terminology, clinical data structures, third party vendor data imports and ability to merge data from outside sources to the case report form clinical data
  • Knowledgeable in SDTM and working experience utilizing SDTM datasets for programming purposes, i.e., data reports, displays, visualizations, etc. is preferred
  • Familiarity with one or more of the following tools used in reviewing/reporting clinical data is beneficial: J-Review, JMP, JMP Clinical, Tableau
  • Programming experience in Iron Python, JavaScript, R, HTML and TERR
  • Proficient in computer technology used in an office environment (Microsoft Word and Excel). 
  • Knowledge of the clinical trial process and related database experience
  • Ability to setup and host team meetings, summarize meeting discussions and initiate cross-functional team discussions when required
  • Ability to work independently with minimal supervision and excellent written and oral communication skills are required

How will you grow with us?

With key regulatory milestones approaching for its lead product candidate, and other pipeline assets advancing in the clinic, Acceleron is entering one of the most exciting periods in its history.  As the lead clinical programmer on all of Acceleron’s clinical programs, you will significantly contribute to the advancement of our pipeline by implementing new technologies and process improvements as well as influence innovation and strategy for the team.  You will work with a team-oriented and dedicated group who will welcome your innovative ideas while motivating and challenging you along the way.  Help us in our mission of transforming the lives of patients and join our team! 

*In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.

*Recruiters - please do not send unsolicited resumes to this posting.

FOR IMMEDIATE CONSIDERATION PLEASE SUBMIT YOUR RESUME TO:

www.acceleronpharma.com

Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. Acceleron’s leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair. Acceleron focuses its research, development, and commercialization efforts in pulmonary and hematologic diseases. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension (PAH), having reported positive topline results of the PULSAR Phase 2 trial. The Company is currently planning multiple Phase 3 trials with the potential to support its long-term vision of establishing sotatercept as a backbone therapy for patients with PAH at all stages of the disease. Acceleron is also investigating the potential of its early-stage pulmonary candidate, ACE-1334, which it plans to advance into a Phase 1b/Phase 2 trial in systemic sclerosis-associated interstitial lung disease (SSc-ILD) this year. In hematology, REBLOZYL® (luspatercept-aamt) is the first and only erythroid maturation agent approved in the United States, Europe, and Canada for the treatment of anemia in certain blood disorders. REBLOZYL is part of a global collaboration partnership with Bristol Myers Squibb. The Companies co-promote REBLOZYL in the United States and are also developing luspatercept for the treatment of anemia in patient populations of myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. For more information, please visit www.acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn.

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This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.