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Senior Manager, Statistical Programming

2 months ago

Cambridge, United States Bicycle Therapeutics Full time

Bicycle Therapeutics is a clinical-stage pharmaceutical 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 zelenectide pevedotin (formerly BT8009), a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule 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, Mass.

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 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

  • 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

  • exible 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.