Bicycle Therapeutics
Senior Manager, Statistical Programming
Bicycle Therapeutics, Cambridge, Massachusetts, us, 02140
Company Description
Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating BT8009, a Bicycle Toxin Conjugate (BTC) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist (Bicycle TICA) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle Radio Conjugates (BRC) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle technology to develop therapies for diseases beyond oncology.Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA.Culture
is key and all Bicycle employees actively embrace and role model our company values:We are
Adventurous . We believe it’s the way to deliver extraordinary results for our patients.We are
Dedicated to our Mission . You can’t change the world if you don’t have determination.We are
One Team . We only succeed when we work together.Job Description
The Senior Manager Statistical Programming will act as statistical programming lead for various clinical studies. You will collaborate with Biostatisticians and Statistical Programmers and ensure high quality and timely statistical programming deliverables. You also will perform oversight on the counterpart from vendors. You will report to Senior Director, Statistical Programming.You should demonstrate leadership competencies and have extensive experience in SAS programming within biopharmaceutical clinical trials environment and in-depth understanding of CDISC standards and drug development principles, preferably in solid tumor therapeutic area.Collaborate closely with Biostatistics, Data Management, Medical, Safety, Clinical Research, Clinical Operation, and other functions within Bicycle Therapeutics to address their needs for statistical programming supportDevelop and validate programming specification for table, listing, and figureDevelop and validate SAS program that generate table, listing, and figureApply knowledge of CDISC SDTM and ADaM to develop and validate SDTM annotated CRF, SDTM mapping specification and ADaM specificationDevelop and validate SAS program that generate SDTM and ADaM datasetCreate and validate files necessary to support electronic submission in eCTD formatConduct statistical programming and/or statistical simulations to support clinical decision making, regulatory interaction, and publicationSupport development of CRF, edit check, review of Data Transfer Specification, and any other collaborations with Data Management functionQualifications
Good Clinical Practice (GCP) proficientBroad and advanced knowledge of Biostatistics and relevant disciplines related to clinical development and clinical studies, preferably in solid tumor therapeutic areaProficient programming skills using SAS. In-depth experience on BASE SAS, SAS/STAT, SAS MacroAbility to independently manage multiple projects, strong problem-solving skills, and excellent teamwork spiritExcellent communication skills, both written and verbalAdditional Information
Flexible working environmentCompetitive reward including annual company bonusMedical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the CompanyHealth and Dependent Care Flexible Spending Accounts401(k) plan with a 4% Company match and immediate vestingEligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional daysEmployee assistance programEmployee recognition schemes10 Company holidaysCompetitive Family Leave PolicyEligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.All your information will be kept confidential according to EEO guidelines.Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.
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Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating BT8009, a Bicycle Toxin Conjugate (BTC) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist (Bicycle TICA) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle Radio Conjugates (BRC) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle technology to develop therapies for diseases beyond oncology.Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA.Culture
is key and all Bicycle employees actively embrace and role model our company values:We are
Adventurous . We believe it’s the way to deliver extraordinary results for our patients.We are
Dedicated to our Mission . You can’t change the world if you don’t have determination.We are
One Team . We only succeed when we work together.Job Description
The Senior Manager Statistical Programming will act as statistical programming lead for various clinical studies. You will collaborate with Biostatisticians and Statistical Programmers and ensure high quality and timely statistical programming deliverables. You also will perform oversight on the counterpart from vendors. You will report to Senior Director, Statistical Programming.You should demonstrate leadership competencies and have extensive experience in SAS programming within biopharmaceutical clinical trials environment and in-depth understanding of CDISC standards and drug development principles, preferably in solid tumor therapeutic area.Collaborate closely with Biostatistics, Data Management, Medical, Safety, Clinical Research, Clinical Operation, and other functions within Bicycle Therapeutics to address their needs for statistical programming supportDevelop and validate programming specification for table, listing, and figureDevelop and validate SAS program that generate table, listing, and figureApply knowledge of CDISC SDTM and ADaM to develop and validate SDTM annotated CRF, SDTM mapping specification and ADaM specificationDevelop and validate SAS program that generate SDTM and ADaM datasetCreate and validate files necessary to support electronic submission in eCTD formatConduct statistical programming and/or statistical simulations to support clinical decision making, regulatory interaction, and publicationSupport development of CRF, edit check, review of Data Transfer Specification, and any other collaborations with Data Management functionQualifications
Good Clinical Practice (GCP) proficientBroad and advanced knowledge of Biostatistics and relevant disciplines related to clinical development and clinical studies, preferably in solid tumor therapeutic areaProficient programming skills using SAS. In-depth experience on BASE SAS, SAS/STAT, SAS MacroAbility to independently manage multiple projects, strong problem-solving skills, and excellent teamwork spiritExcellent communication skills, both written and verbalAdditional Information
Flexible working environmentCompetitive reward including annual company bonusMedical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the CompanyHealth and Dependent Care Flexible Spending Accounts401(k) plan with a 4% Company match and immediate vestingEligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional daysEmployee assistance programEmployee recognition schemes10 Company holidaysCompetitive Family Leave PolicyEligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.All your information will be kept confidential according to EEO guidelines.Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.
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