Jobs
>
Cambridge

    Senior Manager, Statistical Programming - Cambridge, United States - Bicycle Therapeutics

    Bicycle Therapeutics
    Bicycle Therapeutics Cambridge, United States

    6 days ago

    Default job background
    Description

    Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need. Bicycle is headquartered in Cambridge, UK, and our US operations run out of Cambridge, MA.

    Culture is key and all Bicycle employees actively embrace and role model our company values:

    • WeareAdventurous.We believe it'sthewaytodeliverextraordinaryresultsforourpatients.
    • WeareDedicatedtoourMission.Youcan'tchangetheworldifyoudon'thavedetermination.
    • WeareOneTeam.Weonlysucceedwhenweworktogether.

    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 support
    • Develop and validate programming specification for table, listing, and figure
    • Develop and validate SAS program that generate table, listing, and figure
    • Apply knowledge of CDISC SDTM and ADaM to develop and validate SDTM annotated CRF, SDTM mapping specification and ADaM specification
    • Develop and validate SAS program that generate SDTM and ADaM dataset
    • Create and validate files necessary to support electronic submission in eCTD format
    • Conduct statistical programming and/or statistical simulations to support clinical decision making, regulatory interaction, and publication
    • Support development of CRF, edit check, review of Data Transfer Specification, and any other collaborations with Data Management function

    Qualifications

    Essential:

    • Good Clinical Practice (GCP) proficient
    • Broad and advanced knowledge of Biostatistics and relevant disciplines related to clinical development and clinical studies, preferably in solid tumor therapeutic area
    • Proficient programming skills using SAS. In-depth experience on BASE SAS, SAS/STAT, SAS Macro
    • Ability to independently manage multiple projects, strong problem-solving skills, and excellent teamwork spirit
    • Excellent communication skills, both written and verbal

    Additional Information

    • Flexible working environment
    • Competitive reward including annual company bonus
    • Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company
    • Health and Dependent Care Flexible Spending Accounts
    • 401(k) plan with a 4% Company match and immediate vesting
    • Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional days
    • Employee assistance program
    • Employee recognition schemes
    • 10 Company holidays
    • Competitive Family Leave Policy
    • Eligibility 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.

  • AbbVie

    Pipeline - Manager, Statistical Programming (Remote)

    1 week ago

    AbbVie Boston, United States

    **Company Description** · The Manager of Statistical Programming is a strategic role which guides a team of Statistical Programmers in the research and development of new pharmaceutical products. This role is directly responsible for leading the statistical programming activities ...

  • Moderna

    Manager, Statistical Programming

    1 week ago

    Moderna Cambridge, United States

    The Role: · This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Manager of Statistical Programming will be responsible for statistical programming delivera ...

  • BioSpace, Inc.

    Manager, Statistical Programming

    1 week ago

    BioSpace, Inc. Cambridge, United States

    Job Details · The Role: · This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Manager of Statistical Programming will be responsible for statistical progr ...

  • Moderna, Inc.

    Manager, Statistical Programming

    1 week ago

    Moderna, Inc. Cambridge, United States Full time

    The Role: · This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Manager of Statistical Programming will be responsible for statistical programming deliverab ...

  • Moderna, Inc.

    Manager, Statistical Programming

    1 week ago

    Moderna, Inc. Cambridge, United States Full time

    The Role: · This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Manager of Statistical Programming will be responsible for statistical programming deliverab ...

  • ProClinical

    Director, Statistical Programming

    1 week ago

    ProClinical Boston, MA, United States

    Director, Statistical Programing - Permanent - RemoteProclinical is actively seeking a Director of Statistical Programming for a global biotechnology company. This is a permanent role with the opportunity to work remotely.Primary Responsibilities:This role is pivotal in developin ...

  • Proclinical

    Director, Statistical Programming

    2 weeks ago

    Proclinical Boston, United States Permanent

    Director, Statistical Programing - Permanent - RemoteProclinical is actively seeking a Director of Statistical Programming for a global biotechnology company. This is a permanent role with the opportunity to work remotely. · Primary Responsibilities:This role is pivotal in develo ...

  • Vertex Ventures HC

    Senior Manager, Statistical Programming

    1 week ago

    Vertex Ventures HC Cambridge, United States

    Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists ...

  • Bicycle Therapeutics Limited

    Senior Manager, Statistical Programming

    6 days ago

    Bicycle Therapeutics Limited Cambridge, United States

    Company Description · Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-target ...

  • Bicycle Therapeutics

    Senior Manager, Statistical Programming

    3 days ago

    Bicycle Therapeutics Cambridge, United States

    Job Description · Job DescriptionCompany Description · Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell a ...

  • Bicycle Therapeutics

    Associate Director, Statistical Programming

    1 week ago

    Bicycle Therapeutics Cambridge, United States

    Job Description · Job DescriptionCompany Description · Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell a ...

  • Moderna, Inc.

    Associate Director, Statistical Programming

    1 week ago

    Moderna, Inc. Cambridge, United States Full time

    The Role: · This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Associate Director of Statistical Programming will be responsible for statistical programmin ...

  • AbbVie

    Manager, Statistical Programming Operations

    1 day ago

    AbbVie Boston, United States

    Job Description · Job DescriptionCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives acr ...

  • Harvard University

    Associate Director of Statistical Programming

    1 week ago

    Harvard University Boston, United States Full time

    Duties and responsibilities include, but are not limited to, the following:Signatory for CBAR Programming SOPs with responsibility for document revisions, CAPA management, response to internal audit, statistical programming representative for external audit / inspection · Lead Pr ...

  • AbbVie

    Manager, Safety Statistical Programming

    1 week ago

    AbbVie Boston, United States Full time

    Job Description · The Manager of Safety Statistical Programming is a strategic role in the emerging field of safety science providing programming expertise for development of pooled safety data sets and providing technical guidance to team of Statistical Programmers in the resear ...

  • Harvard University

    Associate Director of Statistical Programming

    1 week ago

    Harvard University Boston, United States Full time

    Duties and responsibilities include, but are not limited to, the following:Signatory for CBAR Programming SOPs with responsibility for document revisions, CAPA management, response to internal audit, statistical programming representative for external audit / inspection · Lead Pr ...

  • Dyne Therapeutics

    Associate Director, Statistical Programming

    4 weeks ago

    Dyne Therapeutics Waltham, United States Full time

    Company Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide the ...

  • Moderna

    Manager, Statistical Programming

    2 weeks ago

    Moderna Marlborough, United States

    318 open jobs. · Use your resume to get matched with the right job. · Jobs will be labeled when they're a good or great match · Great matches will be shown first in search results · Relevant skills and experience will be listed so you know why those jobs are a match · Marlboroug ...

  • Biogen

    Executive Director, Head of Statistical Programming, Digital and Data Sciences

    1 week ago

    Biogen Cambridge, United States

    Job Description · Job DescriptionJob Description · About This Role · The Head of Statistical Programming, Digital and Data Sciences is a member of the Quantitative Sciences & Development Operations (QSDO) leadership team and is accountable for the management and direction of glo ...

  • Biogen

    Executive Director, Head of Statistical Programming, Digital and Data Sciences

    1 week ago

    Biogen Cambridge, United States Full time

    Job Description · About This Role · The Head of Statistical Programming, Digital and Data Sciences is a member of the Quantitative Sciences & Development Operations (QSDO) leadership team and is accountable for the management and direction of global statistical programming, data ...